Medical Hemostat

TRALI - further evidence to minimize transfusion

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 15 Feb 2012 21:27:00 +0000

TRALI

Transfusion-Related Acute Lung Injury (TRALI) is a syndrome characterized by acute respiratory distress following transfusion. All plasma-containing blood products have been implicated including rare reports of IVIG and cryoprecipitate. It is a rare complication of allogeneic blood transfusion but the incidence has not been well established due to difficulty in defining the syndrome and to variable reporting mechanisms worldwide. Various studies have estimated the overall frequency of TRALI to be between 1/1,120 and 1/57,810 units transfused. However, there is wide discrepancy in the literature with the reported frequency is as low as 1/557,000 RBC units and as high as 1/432 platelet units.

TRALI is associated with a high morbidity with the majority of patients requiring ventilatory support. However, the lung injury is generally transient with PO2 levels returning to pretransfusion levels within 48 -96 hours and CXR returning to normal within 96 hours. TRALI is associated with a significant mortality rate, often approximated at 5 to 10%. Given the gains in safety made within the blood component production industry, particularly with respect to transmission of infectious diseases, TRALI is now among the three leading causes of transfusion related fatalities along with ABO incompatibility and bacterial contamination.

Transfusion-related acute lung injury and pulmonary edema in critically ill patients: a retrospective study.

Rana R, Fernández-Pérez ER, Khan SA, Rana S, Winters JL, Lesnick TG, Moore SB, Gajic O.

Source

Division of Pulmonary and Critical Care Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.

Abstract

BACKGROUND:

Using the recent Consensus Panel recommendations, we sought to describe the incidence of transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) in critically ill patients.

STUDY DESIGN AND METHODS:

Consecutive patients at four intensive care units (ICUs) who did not require respiratory support at the time of transfusion were identified with custom electronic surveillance system that prospectively tracks the time of transfusion and onset of respiratory support. Respiratory failure was defined as the onset of noninvasive or invasive ventilator support within 6 hours of transfusion. Experts blinded to specific transfusion factors categorized the cases of pulmonary edema as permeability edema (suspected or possible TRALI) or hydrostatic edema (TACO) according to predefined algorithm. In a nested case-control design, transfusion variables and lung injury risk factors were compared between the TRALI cases and controls matched by age, sex, and admission diagnosis.

RESULTS:

There were 8902 units transfused in 1351 patients of whom 94 required new respiratory support within 6 hours of transfusion. Among 49 patients with confirmed acute pulmonary edema, experts identified 7 cases with suspected TRALI, 17 patients with possible TRALI, and 25 cases with TACO. The incidence of suspected TRALI was 1 in 1271 units transfused; possible TRALI, 1 in 534 per unit transfused; and TACO, 1 in 356 per unit transfused. When adjusted for sepsis and fluid balance in a stepwise conditional logistic regression analysis, patients who developed acute lung injury (suspected or possible TRALI) received larger amount of plasma (odds ratio 3.4, 95% confidence interval 1.2-10.2, for each liter infused; p = 0.023).

CONCLUSION:

In the ICU, pulmonary edema frequently occurs after blood transfusion. The association between infusion of plasma and the development of suspected or possible TRALI may have important implications with regards to etiology and prevention of this syndrome.

Link: http://www.ncbi.nlm.nih.gov/pubmed/16965572

Revealed - UK NHS tests for Transfusion related vCJD. US California new cases.

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sun, 12 Feb 2012 22:27:00 +0000

In More Bad news for purveyors of Bovine derived products and transfusion supporters, thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections.

Experts advising the Department of Health believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease because it can be passed on through infected blood.

They say monitoring these patients could give vital clues about the way the disease develops and is transmitted from person to person and could help work out whether there are likely to be further deaths.

Thousands of NHS patients could be secretly monitored by the Government for symptoms of the human form of mad cow disease amid concerns that there could be another wave of infections

It could also inform officials whether the risk from blood donations needs to be treated more seriously.

But they are considering conducting their surveillance secretly because they fear that informing patients they are at risk and are being monitored will cause unnecessary alarm.

The proposals have been discussed by a powerful panel of leading scientists and doctors, which advises the Government on the disease, known as variant CJD.

More...

The panel's report, published online, suggests conducting 'covert health surveillance' of around 30,000 patients known to have received a high number of blood transfusions.

Experts would expect to see at least 150 cases of vCJD in this group of patients, based on scientific evidence that between one in 4,000 and one in 20,000 of the population may be infected.

Experts believe patients who have received more than 80 blood transfusions are most at risk of developing the fatal brain disease as it can be passed on through infected blood

But this has so far not been seen and may either mean the risk is lower than previously thought, or that it is taking longer for cases to develop.

The 'highly transfused' group includes people suffering life-threatening illnesses including acute leukaemia, aplastic anaemia and the blood disorder thalassemia - as well as those with multiple injuries due to road accidents, or heavy blood loss from aneurysms.

The report acknowledges that following patients without their consent is 'ethically problematic'.

But the panel, a subcommittee of the Advisory Committee on Dangerous Pathogens, has asked the Health Protection Agency to set out the various options for monitoring these patients based on seeking their consent or not.

Chris James, chief executive of the Haemophilia Society, said: 'We are shocked to learn there was ever any suggestion of non-consensual monitoring.

'Given the history of contaminated blood in the 1970s and 1980s, the maintenance of medical ethics is especially important to the haemophilia community.

'Any proposed framework must be reviewed by an ethics committee and open to challenge from individuals and organisations such as ourselves through a formal consultation process.'

Latest official figures show seven NHS patients have died from vCJD after having blood transfusions.

Four are known to have been given blood from people who were infected with fatal vCJD, and the other three had previously had transfusions although it is not known whether the blood was contaminated.

Since the first vCJD cases emerged in the mid-1990s, 175 people in Britain have died from the brain wasting disease, which is linked to eating beef infected with BSE.

Experts predicted that hundreds more could die after receiving blood infected with the disease. But they now admit they are baffled as to why these cases have failed to emerge.

One theory is that some people have a genetic advantage and may only carry the disease without developing symptoms. However, they can still infect others if they give blood.

In one case, a patient is known to have been exposed to vCJD in a blood transfusion and is still alive 24 years later.

A memorial plaque to victims of Human BSE on the Riverside Walk near Westminster Bridge, London

At the moment, patients are only informed that they are at increased risk of developing vCJD if they have been exposed to blood from more than 80 donors and if they are about to have brain, spinal or complex eye surgery.

But this threshold may now be raised to only inform patients if they are exposed to 300 or more blood donors because the lack of vCJD cases so far may indicate that the risk of catching vCJD in blood may be lower than previously suspected.

Judy Kenny, of the CJD Support Network, whose husband Deryck died aged 69 in 2003 after being given contaminated blood, said: 'If the authorities are going to do any monitoring, patients should be aware of it.

'There is no grey area - if they are thinking about unconsented monitoring, then it is wrong.'

CJD occurs when nerve-tissue proteins called prions (illustration above) turn 'bad' and gradually destroy the brain

Professor Chris Bunce, science director of charity Leukaemia and Lymphoma Research, said: 'The extent of the risk [of vCJD] to patients who receive regular blood transfusions as part of their treatment is as yet uncertain.

'One way to ascertain the risk would be to monitor the distribution of the pathogen among people in this group.

'But with that comes the moral question of whether patients should be informed or not, and this is the dilemma of the Health Protection Agency.'

A Department of Health spokesman said: 'No decisions have been taken on any unconsented follow-up of highly transfused patients.

'No unconsented follow-up has taken place and none would without appropriate ethical approval and on the basis of legal advice.

Meanwhile Stateside...
(Sacramento, CA)
Friday, February 10, 2012

The Marin County Public Health Officer, Dr. Craig Lindquist, says one person who was diagnosed with a brain disorder similar to Mad Cow Disease has passed away, but that the person did not contract the disease from contaminated beef. That makes it the classic form of the disease and not the varient form.

There is another resident still living with Creutzfeldt Jacob Disease or CJD. Lindquist says there is no evidence it is of the varient variety either.

CJD is very rare, but always fatal. It attacks the memory, hand eye coordination and vision before killing the victim within a year.

The Mad Cow variant of the disease can be spread only by contact with the brain tissue or nervous system tissue of someone or something that is afflicted. Twenty five years ago, nearly 170 people died of the variant form of the disease in Europe.

Doctor Richard Breitmeyer runs the lab at UC Davis that tests Mad Cow disease in sheep and cattle.

BREITMEYER: "The current science believes in the United Kingdom that was the cause of Varient CJD in people in that they had consumed meat products that were contaminated with the bovine form."

Breitmeyer's lab is one of six in the nation.

Cattle fed with bovine bone meal was found to be a significant cause of the spread of the disease in Europe. Of the 40,000 animals tested each year in the United States since, only two tested positive.

In humans, 85 percent of those afflicted with classic CJD had no known risk factors. Five to ten percent had a genetic history of the disease.

Baxter Announces FDA Approval of Expanded Indication for TISSEEL

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sun, 05 Feb 2012 03:37:00 +0000

DEERFIELD, Ill., Jan 30, 2012 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved TISSEEL [Fibrin Sealant] to include general hemostasis in surgery when control of bleeding by standard surgical techniques is ineffective or impractical. TISSEEL is effective in heparinized patients. TISSEEL mimics the final stages of the body's own blood clotting cascade, creating a clot that adheres to the wound surface and helps achieve hemostasis.

"The expanded indication for TISSEEL offers more surgeons an effective tool for controlling bleeding across a wider variety of surgical procedures," said Sibu Saha, M.D., Professor of Surgery, University of Kentucky. "This includes patients who have been treated with heparin who may have unique treatment challenges, which was the case for some of the patients involved in Baxter's clinical trials."
A Phase III clinical study assessed the safety and efficacy of TISSEEL in peripheral vascular surgery compared with manual compression, a standard of care, in 140 evaluable patients (70 patients per treatment arm). In the study, TISSEEL was shown to be statistically significantly better than manual compression in achieving hemostasis. These study results complement a clinical data package showing the safety and effectiveness of the use of TISSEEL as an adjunct to hemostasis.
"TISSEEL and its multiple application devices make it well-suited for a variety of surgical situations, such as open and laparoscopic procedures, reinforcing Baxter's commitment to supporting solutions to the surgical community," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience busines

Important Risk Information

For Topical Use Only. Do not inject TISSEEL directly into the circulatory system or into highly vascularized tissue. Intravascular application of TISSEEL can lead to intravascular coagulation, may result in life-threatening thromboembolic events and may increase the likelihood of acute hypersensitivity reactions in susceptible patients. Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery.

Do not use TISSEEL in individuals with a known hypersensitivity to aprotinin.

Do not use TISSEEL for the treatment of severe or brisk arterial or venous bleeding. In these situations, TISSEEL will be washed away in the flow of blood before hemostasis can be attained.

Hypersensitivity or allergic/anaphylactoid reactions may occur with the use of TISSEEL. Such reactions may especially be seen if TISSEEL is applied repeatedly over time or in the same setting, or if systemic aprotinin has been administered previously.

Aprotonin is known to be associated with anaphylactic reactions. Even in the case of strict local application of aprotinin, there is a risk of anaphylactic reactions to aprotinin, particularly in the case of previous exposure.

Discontinue administration of TISSEEL in the event of hypersensitivity reactions. Remove remaining product from the application site.

Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This may occur if a spray device is used at higher than recommended pressures and in close proximity to the tissue surface.

When using the EASYSPRAY device, or an equivalent spray device for open surgical procedures cleared by FDA, TISSEEL must not be sprayed in enclosed body areas and must be sprayed onto only visible application sites.

TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals. If any of these substances have been used to clean the wound area, the area must be thoroughly rinsed before the application of TISSEEL.

Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set. Excess clot thickness may negatively interfere with wound healing.

The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated; its use in this setting is not FDA approved.

TISSEEL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Vascular Solutions Reports Q4

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 01 Feb 2012 21:31:00 +0000

Net sales of hemostat products (mainly consisting of D-Stat(R) Dry, D-Stat Flowable, and D-Stat Radial) were $5.5 million, down 6% from the year-ago fourth quarter and a 4% decline from the September quarter level. "The hemostatic patch market remains intensely competitive and price sensitive," Mr. Root said. "In mid-2011, we launched the new Silver versions of our D-Stat Dry and Thrombix(R) products, which add an antimicrobial agent. We believe these new products will help us maintain our market-leading position in the hemostat patch market in 2012."
Vascular Solutions will host a live webcast starting at 3:30 p.m., Central Time today to discuss the information contained in this press release. The live webcast may be accessed on the investor relations portion of the company's web site at www.vasc.com . An audio replay of the call will be available until Wednesday, February 8, 2012, by dialing 1-888-203-1112 and entering conference ID# 3945548. A recording of the call will also be archived on the Company's web site, www.vasc.com until Wednesday, February 8, 2012. During the conference call the Company may answer one or more questions concerning business and financial developments and trends, the Company's view on earnings forecasts and new product development and financial matters affecting the Company, some of the responses to which may contain information that has not been previously disclosed.

Baxter International's CEO Discusses Q4 2011 - and the International Markets

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 01 Feb 2012 21:19:00 +0000

Robert L. Parkinson
...In our regenerative medicine business, we achieved a number of milestones, including the approval and U.S. launch of ARTISS Fibrin Sealant for use in facial surgery and the U.S. regulatory filing for TISSEEL Fibrin Sealant for vascular surgery providing a broad hemostasis label. As we've previously mentioned, we're very pleased with the publication of data from Baxter's Phase II chronic myocardial ischemia adult stem cell program, which was published in the scientific journal Circulation Research....
Third, we recently announced the definitive agreement to acquire Synovis, an acquisition that complements and expands Baxter's regenerative medicine and biosurgery franchise, including a number of devices and biological products for hemostasis, tissue sealing and adherence.

Robert J. Hombach

Yes. And so net-net, not much of an impact to speak of on the base of $4.31 of earnings. But as we move into 2012, clearly, we're projecting a much more pronounced impact. And maybe I'll just take a minute here and kind of walk everyone through the drivers because I think this is important. As we've talked about, regularly, Baxter has about 60% of our revenues outside the U.S. We've increasingly highlighted for investors that now slightly more than 20% of our revenues come from emerging markets. And in fact, emerging markets have been growing 2 to 3 times the rate of developed markets over the last 5 years. So the mix of our business certainly has shifted towards emerging markets to a much greater degree. As we've highlighted in the past, for developed markets, we have the ability through natural hedges given our manufacturing footprint, which we have in places like Europe and Canada and Japan, Australia and so on. We have some natural hedges there, but also we utilize financial hedges in those developed markets. Now I would pause here to say, as we've talked about in the past, our pipe policy, we hedge 80% of our projected exposures. And by the nature of hedging, when you're looking 12 to 18 to 24 months out, you have to be careful in your projections to ensure that you don't get yourself in an overhead situation, hence, the 80% with a 20% buffer. But what that does mean is we do have some residual exposure muted but some residual exposure in the developed markets. As we said in the past, with emerging markets, we do not hedge. We do not utilize financial hedges, and we have modest natural hedges in some manufacturing facilities in Latin America, Eastern Europe and so on but nothing near the degree we have in the developed markets. And so our bottom line drop to exposure on the emerging markets is much more leveraged. So to frame that exposure for you then, looking at it by region, so within Latin America, from an operating profit perspective that would be exposed to foreign currency, think of that in terms of $300 million to $400 million of annual profit. And that's primarily Brazil, Colombia and Mexico. For Eastern Europe, which is primarily Russia, Poland and Turkey, again, about $300 million of operating profit on an annual basis. And then in Asia Pacific, and there we would exclude Japan, Australia, New Zealand and China because of the stability of the currency, so all of Asia excluding those 3 is another roughly $300 million of operating profit on an annual basis. So you add that up. That's $900 million to $1 billion of profit exposed to currency in emerging markets. And as you've seen, there's been quite a bit of volatility, and given where we're sitting today and where rates are today relative to where they were on average in 2011, if you assume an 8% to 10% weakening across that basket of emerging market currencies, that's $80 million to $100 million of incremental exposure that we're factoring in here. And you add to that the slight 20% residual impact from the developed markets that goes unhedged, and that's how we get into this kind of $0.15 to $0.18 range of FX exposure. Now, as you would imagine, given the volatility, we've assumed somewhat conservative rates relative to where market rates are today. There's been of bit of a run-up here in the last few days, but given the volatility, I hesitate to call it very conservative. And so that's the picture. But if I step back and think about as a large U.S. multinational corporation in thinking about the long run, being along the emerging markets, whether it's from a growth perspective or currency perspective, is exactly where we want to be. We continue to see great opportunities there, but in times of financial crisis like this, where the correlation between those currencies and the U.S. dollar is all going one way, it creates this kind of outsized exposure that we're having to factor into our guidance here for 2012. So thanks for bearing with me, but I think it's important that people understand the breadth of the issue for us.

David R. Lewis - Morgan Stanley, Research Division

I will -- just maybe one more quick one for Bob Parkinson. And Bob, there's been a lot of concerns here in the quarter regarding European austerity. You've talked a lot about old Europe pressures. I guess we've been surprised about where that pressure's coming from. I think it's a little different than where the investor sees within your plasma business versus your injectable and your nutritional business. Can you just sort of talk to us in the way you're see the pressure and which businesses for Baxter are proving to be more robust? And then where -- which businesses are seeing sort of more pharmaceutical-like pressure?

Robert L. Parkinson

Yes. I mean, so the negative impact of the austerity measures, first of all, is just kind of what I call general softness, David, and underlying demand. But these are the kind of things we see globally. So surgical procedures and things of that nature are somewhat softer than what's been reflected historically. So now we'd run across virtually all our businesses, certainly even our IV business and so on and so forth. But the other pressure that's probably more pronounced and is more associated with our BioScience business would be pricing pressures with governments who clearly are under the gun to implement austerity measures. And given healthcare spend and well-large item that represents on national budgets and so on, we continue to see governments virtually unilaterally implementing various pricing actions, and that impact is more pronounced in things like, say, biosurgery where people are making trade-off decisions in terms of clinical options that they have but also, most of our BioScience products, which are more expensive. So as an example, countries like France implement actions in terms of taking prices down. It's a haircut, David. So it's not as pronounced as what you would see with some of the tender actions, I would say, on hemophilia because encouragingly, we haven't seen the expansion beyond the Anglo markets of the tender activity for hemophilia. But -- so we think we've captured in our guidance for next year those known pricing actions that will be taken on a country-by-country basis. We also think we've reflected kind of the underlying softness of demand. But I think we have to be cognizant of the fact that given the extreme austerity measures and pressures that exist that unlike the U.S. governments in Europe, most notably, really have a history of implementing unilateral actions for which there's not a lot of control. We think we've captured it, but like I say, given the environment, I think, we have to be cognizant that there could be more there. And by the way, this is an ongoing thing. I mean, this is -- it's why I talk about dealing with the new environment in our company, in our culture and so on. This isn't something that's going to pass through this year in -- or through the end of 2012. It's going to be with us....

David H. Roman - Goldman Sachs Group Inc., Research Division

Okay. And then as I look at the Plasma Protein business, the issues about timing of imports in China, I think you had talked about that last quarter, as well a new product, the delay on a large tender for PD Factor VIII in Brazil. Are those issues that we should think about as being ongoing for the next several quarters? Or will those normalize at some point, whereby that business gets back to sort of stable underlying growth on a reported basis?

Robert J. Hombach

Yes. Certainly, Brazil for sure is a timing issue, and we're hoping to continue to accelerate into China. Without them it becomes -- it is a great growth opportunity. So yes, you should see normalized growth rates here in 2012 for that category.

Mary Kay Ladone

Although I would mention, David, that tenders tend to be volatile, and we can see shifts from quarter-to-quarter, so just to highlight that.

Robert L. Parkinson

David, the one thing I would add to the China situation, there's been local action by the Chinese government to further scale back some of their local plasma collection operations in the country. So this importation of albumin in China would appear to be something that is going to be sustainable for the near future, certainly over the next few years, I think, given some of the local issues they manage through.

FDA Approves Surgical Adhesive for U.S. Study

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 01 Feb 2012 20:58:00 +0000

The Food and Drug Administration has issued Investigational Device Exemption approval to Cohera Medical's TissuGlu surgical adhesive, opening the door for a prospective, multi-center, randomized clinical trial of the product in the U.S.

According to the Pittsburgh, Pa.-based manufacturer, the absorbable internal surgical adhesive, intended for the sealing of tissue in large-flap surgeries such as abdominoplasty, can prevent fluid accumulation in post-op wounds. This would reduce the need for surgical drains and possibly speed patients' recoveries.

At present, says Cohera Medical, no synthetic adhesive product is available or in clinical trials for use in large-flap tissue surgeries. TissuGlu received the European Union's safety and effectiveness approval last year, and is scheduled to begin U.S. testing in the first quarter of this year.

ProFibrix US Phase II Study with FibrocapsTM Meets All Primary and Secondary Endpoints

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Thu, 05 Jan 2012 20:53:00 +0000

ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to hemostasis (TTH) and incidence of hemostasis at 3, 5 and 10 minutes, as compared to active control.

A total of 70 patients were enrolled in the company’s U.S., prospective, randomized, single-blind, controlled, multicenter Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The US study results confirm the efficacy and safety results recently reported from the Dutch Phase II study in hepatic resection. Both studies demonstrate that Fibrocaps has a very good safety profile comparable to active control, along with rapid hemostatic activity across multiple surgical indications.

Dr. Neil Singla, one of the Principal Investigators of the US Phase II study, said: “The combined ease of use and efficacy of Fibrocaps in spinal and vascular surgery constitute a great leap forward in hemostasis in these surgical settings. These surgeries require optimal precision and thanks to the rapid time to hemostasis of Fibrocaps we can quickly and safely obtain a clear field of vision during these interventions.”

Jan Öhrström, CEO of ProFibrix said: “We are delighted that the positive results of the US Phase II study confirm the results from our European study reported in November 2011. In fact, the results of the two Phase II clinical trials have de-risked the Fibrocaps program substantially. We plan to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. Based on its strong and competitive properties, we believe that after launch Fibrocaps should be able to command a large share of the US$ 1 billion topical hemostat market.”

About Fibrocaps

Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.

About the Study

The Phase II clinical trial of Fibrocaps (FC-002 US) was a prospective, randomized (2:1), single-blind, controlled study in 70 subjects undergoing spinal (n=37), peripheral vascular (n=30) and general surgery (n=3). The study was conducted at 8 sites across the U.S. Fibrocaps was considered to have a very good safety profile, with no adverse events attributed to Fibrocaps, which is consistent with the previously conducted Phase II study. The primary efficacy endpoint of the study was a pooled intent-to-treat analysis of the mean TTH of Fibrocaps versus active control. The TTH means ± SD were 1.9 ± 1.3 min for Fibrocaps (n=47) and 4.8 ± 3.1 min for control (n=23) (p<0.001). The secondary endpoints of incidence of hemostasis at 10, 5 and 3 min were all statistically significant, with p-values of 0.003, 0.001 and <0.001, respectively.

ProFibrix conducted the Fibrocaps Phase II study in the U.S. under an open IND with the FDA. For more details on the study, please go to http://www.clinicaltrials.gov.

ProFibrix to present today at Biotech Showcase in San Francisco

ProFibrix will present at the Biotech Showcase 2012 in San Francisco, on Wednesday, Jan. 11, 2012. Jan Öhrström, CEO of ProFibrix, will make a formal presentation on the company at 9:45 a.m. in the Stockton Room. The Biotech Showcase runs parallel to the 30th Annual J.P. Morgan Healthcare Conference, and takes place at Parc 55 Wyndham San Francisco - Union Square.

About ProFibrix

ProFibrix (www.profibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and bring to market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.

Hemostat Market Research Indicates Strong Growth

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 04 Jan 2012 21:38:00 +0000

Source: Mediligence Blog

Transfusion Guidelines in Children Reviewed

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sun, 01 Jan 2012 19:53:00 +0000

December 29, 2011 — Thresholds for transfusing children vary from those in adults, according to a 2-part review study published in the January 2012 issue of Anaesthesia & Intensive Care Medicine.

"The transfusion of a blood product into a child is associated with a greater risk of harm when compared to an adult," writes Rachel Hartrey, MBBCh, FRCA, a consultant pediatric anesthetist at Southampton University Hospital National Health Service Trust in the United Kingdom. "The younger the child, the greater these risks are: 18:100,000 in all paediatric age groups, increasing to 37:100,000 in those less than 1 year of age; this compares to 13:100,000 in adults. These calculations are based on red cell transfusion alone and do not take into account risks posed by other blood products, in particular fresh frozen plasma...and platelets."

The first part of the review describes normal hematological ranges in infants and children, lower levels of hemoglobin that can be tolerated without undue risks, and how to evaluate blood loss to ensure that blood products are not transfused unnecessarily.

The second part of the review describes strategies to avoid transfusion of blood products, and which fluids to use instead, as well as recommendations regarding how much and which blood products to use when indicated to reduce adverse effects.

Normal hemoglobin values are highest at birth (14 - 24 g/dL), decreasing to 8 to 14 g/dL at 3 months, and then gradually increasing to 10 to 14 g/dL at age 6 months to 6 years, 11 to 16 g/dL at age 7 to 12 years, and 11.5 to 18 g/dL in adulthood.

Thresholds for Red Blood Cell Transfusions

For infants younger than 4 months, thresholds for red blood cell transfusions based on hemoglobin levels are 12 g/dL for preterm infants or term infants born anemic, 11 g/dL for chronic oxygen dependency, 12 to 14 g/dL for severe pulmonary disease, 7 g/dL for late anemia in a stable infant, and 12 g/dL for acute blood loss exceeding 10% of estimated blood volume.

For infants older than 4 months, thresholds for red blood cell transfusions based on hemoglobin levels are 7 g/dL in a stable infant, 7 to 8 g/dL in a critically unwell infant or child, 8 g/dL in an infant or child with perioperative bleeding, and 9 g/dL in an infant or child with cyanotic congenital heart disease (because of increased oxygen demand). To slow bone marrow stimulation in a child with thalassaemia major, the recommended threshold is 9 g/dL.

For a child with sickle cell disease (SCD), the recommended threshold is 7 to 9 g/dL, or more than 9 g/dL if the child has previously had a stroke. When a child with SCD undergoes major surgery, the threshold should be 9 to 11 g/dL, and sickle hemoglobin should be less than 30%, or less than 20% for thoracic or neurosurgery.

Strategies to Avoid Transfusion

Strategies to avoid perioperative transfusion of allogeneic blood include:

maximizing preoperative hemoglobin;
preoperative autologous donation, which is associated with risks including transfusing the wrong blood unit, wasting donated blood, bacterial contamination, and preoperative anemia;
acute normovolemic hemodilution when major blood loss is expected;
patient position to avoid increased venous pressure;
use of tourniquets where appropriate;
surgical technique to achieve hemostasis, using diathermy and tissue glues;
deliberate hypotension (at a safe level);
hypervolemic hemodilution, although infusing large volumes of fluid may dilute clotting factors and cause interstitial edema;
use of tranexamic acid, although there is still uncertainty as to the most effective dose;
and intraoperative cell salvage in operations in which major blood loss is anticipated. However, reactions to the retransfused blood have been reported, which may be caused by leukocyte stimulation or a reaction to the additives.

"Blood is not only involved in the carriage of oxygen, but has many other functions including haemostasis," Dr. Hartrey writes in the second part of the review. "Therefore it is little wonder that the development of a compound that deals with only one element of this (e.g. oxygen carriage) is compromised by side effects. Several of the proposed alternatives, including haemoglobin-based oxygen carriers...and fluorocarbon-based solutions, have been associated with significant clinical side effects such as abnormal clotting."

Dr. Hartrey has disclosed no relevant financial relationships.

Kenneth Mann named 'Distinguished Scientist'

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Fri, 30 Dec 2011 20:45:00 +0000

A professor from the College of Medicine has recently been recognized by one of the top cardiovascular organizations in the world.

Professor of Biochemistry and Medicine Kenneth Mann, Ph.D was named a Distinguished Scientist by the American Heart Association (AHA), an honor reserved for those whose work has advanced understanding of cardiovascular disease, a University Communications article stated.

The award, created in 2003, progresses the AHA's goal of "building healthier lives, free of cardiovascular diseases and strokes," the article stated.

The research that propelled Mann to Distinguished Scientist status focused on blood coagulation. The National Institutes of Heath, the AHA and other areas in the pharmaceutical industry supported his publication, the article stated.

Mann's early career focused on the production of the protein thrombin and pharmaceuticals' influence on it, University Communications stated.

Mann and his research team have focused on computer simulation and clinical trials to determine the effects of various pharmaceuticals on blood clotting and thrombin production, Mann said.

"Because our work flows in through all areas, we cover everything from cardiology to vascular surgery and trauma," he said. "We've even written a lot of current textbooks on blood clotting and hematology."

Mann's contributions have been recognized by various medical associations and have received awards such as the E. Donnall Thomas prize and the Stratton Medal of the American Society of Hematology, according to University Communications.

"I got involved in blood clotting for a lot of reasons, and was mentored and tutored by very nice people over my career," Mann said.

His research career and training of graduate and medical students has produced scientists in the blood coagulation field. Mann attributes his success to his students, collaborators and his wife, Jeanette, the article stated.

Z-Medica Donates $1.5 Million in QuikClot

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sun, 11 Dec 2011 22:45:00 +0000

WALLINGFORD, Conn., Dec 08, 2011 (BUSINESS WIRE) -- Z-Medica Corporation, a medical device company which develops and distributes innovative hemostatic agents, announced that it has donated $1.5 million in QuikClot(R) the company's life-saving hemostatic agents, to AmeriCares, a nonprofit global health and disaster relief organization. The QuikClot products will be used by AmeriCares for disaster relief efforts as well as its ongoing health programs around the globe, helping to prevent loss of life and limb. Z-Medica had previously donated $150,000 of its QuikClot products to AmeriCares for use in Haiti following the earthquake there in 2010.

"We had great success providing QuikClot for use in Haiti following the earthquake and for other relief efforts and we are grateful that Z-Medica has responded to our request for an additional donation of this life-saving tool," said Dr. Frank J. Bia, AmeriCares Medical Director. "QuikClot is now a standard part of our response efforts and we make sure it is part of our aid deliveries for disasters and our ongoing partnerships."

QuikClot is an ideal product for use in the field, including disaster relief areas or by first responders, due to its ease-of-use and ability to achieve hemostasis in as little as three minutes. The United States Department of Defense currently uses QuickClot Combat Gauze(TM) as the official first-line hemostatic treatment for traumatic bleeding in all branches of the United States military. QuikClot is also regularly used by first-responders and medical professionals in the field and in hospital clinical environments such as the cardiac catheterization laboratory, interventional radiology, the emergency room and virtually anywhere else where bleeding needs to be controlled.

"AmeriCares is an extremely professional and efficient organization and we have the highest confidence that they will save many lives with this donation," said Brian Herrman, Chief Executive Officer, Z-Medica. "Every US soldier, marine, and airman carries QuikClot at all times, which has saved many lives. Our mission at Z-Medica, therefore, is to ensure that all medical professionals and first responders everywhere have access to QuikClot, in both disaster areas, as well as in day-to-day situations such as hospital trauma units, emergency rooms and the cardiac catheterization labs."

Woman's face catches on fire during surgery

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sat, 03 Dec 2011 20:23:00 +0000

A woman's face caught on fire during routine surgery in the US.
Kim Grice, 29, was undergoing surgery to have cysts removed from her brain when her face erupted in flames.
Grice was airlifted to a Burn Unit with burns to her face and neck.
Grice's father, Ted Grice, told a local newspaper his daughter's face had "caught on fire" during surgery.
"The doctors and the hospital are not telling us what happened," he said. "They said they had never seen anything like it before and they are terribly sorry that it happened."
Grice's mother said she was in shock.
"This is not what happens with a routine outpatient surgery."
According to ABC News, however, "flash fires"are not uncommon.
Between 550 and 650 surgical fires occur each year in the US alone. More than half of surgical fires happen inside a patient's airway or on the patient's upper body, while a quarter of surgical fires happen on other parts of the body.
About 70 per cent of "flash fires" are ignited by electrosurgical tools commonly known as Bovies, devices that use a high-frequency electric current to cut tissue or stop bleeding, reported MSNBC.
Twenty per cent of fires are sparked by hot wires, light sources, burrs or defibrillators while about 10 per cent are sparked by lasers.

ProFibrix Phase II with FibrocapsTM Meets Primary Endpoint – On Track for Phase III in 2012

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sun, 20 Nov 2011 20:17:00 +0000

LEIDEN, The Netherlands & SEATTLE--(BUSINESS WIRE)-- ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that its multicenter Phase II clinical trial with Fibrocaps in liver resection surgery resulted in a highly statistically significant 50% reduction in mean time to hemostasis (TTH) compared to active control.
A total of 56 patients were enrolled in the company’s Dutch prospective, randomized, controlled, multi-center Phase II study with lead product Fibrocaps for mild to moderate surgical bleeding. The study results show that Fibrocaps has a very good safety profile along with rapid hemostatic activity that succeeds in significantly reducing mean time to hemostasis, the primary end point of the Phase II trial.
Professor dr. R.J. Porte from the University Medical Center Groningen, the Lead Investigator of the study, said: “We’re very pleased with the excellent performance of Fibrocaps in this Phase II study. I have no doubt that the substantial reduction in mean time to hemostasis we report for Fibrocaps is clinically very meaningful, and demonstrates the strength of this unique dry powder formulation of fibrinogen and thrombin.”
Jan Öhrström, CEO of ProFibrix said: “Our clinical data constitute the strongest result ever reported for fibrin sealants in a Phase II study in this indication. These positive results ensure that we remain on track to initiate a pivotal Phase III trial in H1 2012, and target a BLA filing in 2013. In the coming months we expect to report on the results of the Phase II trial we are running in parallel in the U.S. Altogether we believe that the positive outcome of the European and U.S studies should allow us to generate strong support from investors as we continue developing Fibrocaps and its line extensions.”

BAX Q3 2011

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Fri, 18 Nov 2011 21:40:00 +0000

In terms of individual business performance and beginning with BioScience, global BioScience sales of $1.5 billion increased 9% in the third quarter. Excluding foreign currency, BioScience sales increased 4%. Within the product categories, recombinant sales of $552 million grew 5%. Excluding foreign currency, sales declined 1% as growth of 4% in the U.S. was offset by the expected impact from recent tenders and somewhat slower demand across Europe, given strong performance in the previous quarter. On a year-to-date basis, excluding the impact of tenders we discussed, global recombinant sales growth, excluding currency, is in mid single digits consistent with global market demand.

Moving on to Plasma Proteins. Sales in the quarter were $372 million and advanced 8%. Excluding the impact of foreign currency, sales grew 4%. Growth across the various Plasma Proteins was significantly offset by lower albumin sales as a result of temporary supply constraints and delays in the clearance of shipments in China as a result of new testing guidelines that were implemented there late last year. Combined, these 2 items impacted sales in the quarter by approximately $20 million.

Sales in the U.S. improved sequentially across multiple products in the portfolio, including FEIBA, PD Factor VIII and ARALAST, but were down 8% year-over-year driven primarily by the supply constraints of albumin, whereas, international sales climbed 10% driven by strong demand for FEIBA and PD Factor VIII despite certain tender delays in Eastern Europe.

In Antibody Therapy, sales of $380 million increased 13%. Excluding foreign currency, sales were up 11%, driven by a robust demand for GAMMAGARD LIQUID and the launch of SubQ. Growth in this category of 11% also reflects some ongoing benefits related to Octapharma of at least $20 million in the third quarter.

Sales in regenerative medicine, which includes our BioSurgery products, totaled $143 million and increased 10%. Excluding foreign currency, sales increased 5% driven by high single-digit growth of Fibrin Sealants. This performance was offset by lower ACTIFUSE revenues triggered by the temporary disruption in the U.S. channel resulting from the planned transition to a direct sales model from ApaTech's former distributor model that we mentioned last quarter....

JnJ Q3 2011

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Fri, 18 Nov 2011 21:18:00 +0000

I will now review the Medical Devices & Diagnostics segment results.

Worldwide Medical Devices & Diagnostics segment sales of $6.3 billion grew 1.7% operationally as compared to the same period in 2010. Currency had a positive impact of 4.4 points, resulting in a total sales increase of 6.1%.

Sales in the U.S. were down 0.7%, while sales outside the U.S. increased on an operational basis by 3.9%. Excluding drug-eluting stent, worldwide sales increased over 3% on an operational basis.....
During the quarter, Ethicon received a complete response letter from the U.S. Food and Drug Administration regarding its Biologics License Application or BLA for the Fibrin Pad. The Fibrin Pad is a novel product candidate that combines Ethicon to biomaterials and plasma-derived Biologics to aid in stopping bleeding during surgery. This BLA marks the first of multiple submissions and approvals the company will pursue to deliver this novel product to surgeons and their patients. We are not planning on conducting new clinical trials to support our response. Ethicon is taking a phased approach to the development of the Fibrin Pad, including building a state-of-the-art facility to scale up supply in order to meet anticipated demand.

Ethicon Endo-Surgery achieved operational growth of 3.4% in the third quarter of 2011, with the U.S. sales down 2.5% and sales outside the U.S. up 7.6% operationally. Growth was driven by increased market share for advanced sterilization products and outside the U.S., new product launches and the continued shift to minimally-invasive surgery drove double-digit growth for harmonic products and strong sales results for Endo products....

Steve Beuchaw - Morgan Stanley, Research Division

We'd always be happy to join you in any of those discussions. One other question. I just wanted to get your latest thoughts, Dominic, on where things are headed with the FDA approval processes, both the 5, 10-Ks in for novel technologies. On one hand it seems like we're seeing an acceleration of legislative activity aimed at making these processes simpler, but then on the other hand we see CMS and the FDA working harder to coordinate approval and reimbursement for new technologies. So at this stage, to what extent do you think these are good indicators of where things might go? Maybe 5, 10-Ks get more predictable, and new technologies get a little bit more scrutiny. Where do you see this going?

Dominic J. Caruso

Yes, it's a great question. Look, we would just be speculating if we gave you sort of any definitive kind of position on this. But it is true that there is a movement to try to differentiate, if you will, the products that should get 5, 10-K and rapid approval in the marketplace because of relatively low risk or they're obviously the predicate devices. It's something that should be comparable to the current device and differentiate those from the products that would require more sort of PMA and extensive clinical trials as the products become or those development innovations become more complex. I think a company like Johnson & Johnson having the expertise that we have across a broad portfolio of not only medical device products, but obviously our pharmaceutical business as well positions us very well to have those kinds of discussions and dialogue with the FDA of what's appropriate in evaluating the particular product in question. So I would just say you've made a good observation. I can't predict where it's going to come or how it's going to come out, but I believe that we're in a great position to have that dialogue with the FDA and help them arrive at a sensible solution for the industry.

Vascular Solutions Q3 2011

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Tue, 08 Nov 2011 22:38:00 +0000

Net sales of hemostat products (primarily consisting of the D-Stat Dry, D-Stat Flowable and D-Stat Radial products) were $5.7 million in the third quarter, a decrease of 6% from the third quarter of 2010 and a decrease of 4% from the second quarter of 2011. "The hemostatic patch market has become even more price competitive. At the very end of the second quarter we launched our new Silver versions of the D-Stat Dry and Thrombix(R) products, which add an antimicrobial ingredient to the patches while leaving our pricing unchanged. We continue to expect these Silver versions to allow us to at least maintain our market-leading position in the hemostat patch market into 2012," Mr. Root said.

As previously disclosed, King Pharmaceuticals, Inc. notified Vascular Solutions on July 6, 2011, that it was electing to not proceed further with efforts to obtain a surgical use indication from the FDA for the company's Thrombi-Gel products and to not complete development of the company's Thrombi-Paste products. As a result, Vascular Solutions recognized an additional $2.6 million of license revenue during the third quarter of 2011 as the remaining deferred license revenue originally allocated to the Thrombi-Paste products and the surgical use indication of the Thrombi-Gel products as part of the agreements entered into with King in 2007. Starting in the fourth quarter of 2011, amortization of deferred revenue is expected to be $87,000 per quarter.

Hemostat Products: It appears that revenues will continue to be flat or declining in Vascular Solution’s hemostat product lines. Management cited competitive pricing pressure for Vascular Solution’s D-Stat Dry product. However, the company could see upside if Marine Polymer’s injunction against competitor HemCon is enforced. Marine Polymer was awarded an injunction in September but Hemcon was subsequently given a stay. The injunction would prevent HemCon from selling such products as the HemCon Bandage and the Chitoflex and Dental Dressings. Vascular Solutions management did say that launches of Silver versions of the D-Stat Dry and Thrombix products, which include a new antimicrobial ingredient, would enable the company to maintain hemostat market share.

CRY Q3 10Q, FDA Disapproves Perclot IDE.....Perclot China Trial underway......

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Thu, 27 Oct 2011 23:00:00 +0000

10Q - PerClot and HemoStase
Revenues from the sale of hemostats, consisting of PerClot and HemoStase, decreased 71% for the three months ended September 30, 2011 as compared to the three months ended September 30, 2010. Revenues from the sale of PerClot and HemoStase decreased 40% for the nine months ended September 30, 2011 as compared to the nine months ended September 30, 2010. The revenue decreases in the three and nine months ended September 30, 2011 were primarily due to a decrease in hemostat sales volume in domestic markets, partially offset by an increase in sales volume in international markets. The revenue decrease in the nine months ended September 30, 2011 was also impacted by a decrease in average selling prices, which decreased revenues by 6%.
International hemostat revenues increased 24% for the three months ended September 30, 2011 and 55% for the nine months ended September 30, 2011 as compared to the three and nine months ended September 30, 2010, respectively. This increase is primarily due to an increase in international sales of PerClot in the 2011 periods over the international sales of HemoStase in the corresponding 2010 periods. Management believes that international PerClot revenues have been favorably impacted by the Company’s ability to market PerClot for all surgical specialties, expanding the direct European sales force into Austria, and PerClot’s product performance when compared to other hemostatic agents.
The decrease in domestic sales volume for the three and nine months ended September 30, 2011 was due to the Company’s planned discontinuation of sales of HemoStase in late March 2011. The Company recognized no domestic hemostat sales in the second or third quarters of 2011, subsequent to the discontinuance of HemoStase sales, as PerClot is not yet approved for commercial distribution in domestic markets. The Company anticipates this loss of domestic hemostat sales to result in a decrease in total hemostat sales for the remainder of 2011 when compared to the corresponding 2010 periods.

The Company will not be able to sell PerClot in the U.S. in future years until U.S. Food and Drug Administration (“FDA”) approval is granted. On March 31, 2011 CryoLife filed an Investigational Device Exemption (“IDE”) with the FDA seeking approval to begin clinical trials for the purpose of obtaining Premarket Approval to distribute PerClot in the U.S. On April 29, 2011 the FDA disapproved CryoLife’s IDE filing with numerous comments and questions. CryoLife is currently addressing those comments and questions and anticipates refiling its IDE for PerClot in the fourth quarter of 2011.

Q3 Report - Brackets have been added-
Ashley Lee...

We experienced some delays in getting PerClot approved in certain international markets and some competitive issues in the EU, which leaves us to slightly lower our guidance.

Worldwide BioGlue revenues were up 10% for the third quarter and up 5% for the nine month period. These increases were predominantly driven by volume increases, particularly in Japan, due to the recent launch of the product. This was the largest year-over-year quarterly increase for BioGlue revenues, since third quarter of 2008, and we continue to remain enthusiastic about the opportunity in Japan.

Total sales in the third quarter in Japan were $651,000 and year-to-date in Japan were approximately $1.2 million. To-date, approximately 250 surgeons have been trained and over 160 accounts have ordered product. We expect another large order from Japan before the end of the year.

PerClot sales for the third quarter were $620,000 and were $1.9 million year-to-date. We experienced some delays in getting PerClot approved in certain international markets and some competitive issues in the EU, which leaves us to slightly lower our guidance. However, despite these delays, our international revenues from the sale of powdered hemostats in the third quarter still increased 24% compared to the prior year, and 55% for the nine month period compared to the prior year.

Steve Anderson...As Ashley has discussed earlier in third quarter of 2010, we announced our first technology acquisition and that we have signed a worldwide manufacturing and distribution agreement for a unique powered hemostatic agent PerClot with Starch Medical of San Jose (Shanghai), California (China).
(Chinese) PerClot is an ideal replacement for the hemostatic powder that we had been distributing worldwide. The primary difference is that PerClot’s gross margin will be 80%.....we filed our IDE for PerClot with the FDA in March of this year. The FDA had questions about our submission that we have been addressing. We will be reaching our IDE to the FDA in mid November. We expect to begin the clinical trial for PerClot (Link to current trial Xijing Hospital of Digestive Diseases, Xi'an, Shaanxi, China) during the second quarter of next year. The clinical trial will probably involve about 300 patients, 150 PerClot patients and 150 control patients. We expect that with six months enrollment and three months follow-up of these patients that we will file our PMA in the second quarter of 2013.

In which circumstances does the FDA disapprove or withdraw an IDE?
FDA may disapprove or withdraw approval of an IDE application if FDA finds that:
1. The sponsor has not complied with applicable requirements of the IDE Regulation, any other applicable regulations or statutes, or any condition of approval imposed by an IRB or FDA.
2. The application or a report contains untrue statements or omits required material information.
3. The sponsor fails to respond to a request for additional information within the time prescribed by FDA.
4. There is reason to believe that the risks to the human subjects are not outweighed by the anticipated benefits to the subjects or the importance of the knowledge to be gained, that informed consent is inadequate, that the investigation is scientifically unsound, or that the device as used is ineffective.
5. It is unreasonable to begin or to continue the investigation due to the way in which the device is used or the inadequacy of:
  (i) the report of prior investigations or the investigational plan; (ii) the methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or (iii) the monitoring and review of the investigation.

Q & A...

Matt Dolan - Roth Capital Partners

Great. First question on the guidance, just looking at the revenue at this point it implies maybe around 10% sequential uptick in Q4. So how far below $122 million should we expect or what gets you to that type of sequential uptick, meaning, is there a category that improves something on the macro level that rebounds?

Ashley Lee

We think that the upside is in the Cardiogenesis product line and the PerClot product line as well as potentially BioGlue in Japan.

Matt Dolan - Roth Capital Partners

Okay. But given your guidance on those categories it still requires a pretty big sequential uptick?

Ashley Lee

Yeah well the possibility exists again that we could do better and then we expect to do better in Cardiogenesis, PerClot, and BioGlue in Japan. And that -- we think that that’s, we have more upside in those three areas than the rest of the business.

Matt Dolan - Roth Capital Partners

Okay. And then on the earnings guidance just to clarify, I think the delta between adjusted and GAAP last quarter was $0.05 as supposed to an $0.08 differential at mid year. So I wanted to make sure that that’s the reason for the increase in the earnings guidance? And secondly the implied guidance for Q4 cuts EPS basically in half. So I’m just trying to understand why that would be?

Ashley Lee

The primary driver in non-GAAP, the increase in non-GAAP EPS as compared to the end of the second quarter is primarily due to the shifting of some R&D expenses due to some delays and getting some studies started, as those will be shifting out of 2011 into 2012. As it relates to the fourth quarter we provided for some additional expenses in the fourth quarter this year to account for the ongoing discovery and the acceleration of the discovery in our litigation with Medafor.

Raymond Myers - Benchmark

And that was going to be my next question. So let’s get right to that. Roughly how much Medafor litigation expense should we expect?

Ashley Lee

If you go through the end of the third quarter we had spent about $1.4 million and we’re expecting a similar amount in the fourth quarter of this year about $1.4 million.....

Cryolife announce first patients enrolled for BioFoam (Bovine) trial.

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Thu, 27 Oct 2011 21:50:00 +0000

ATLANTA, Oct. 24, 2011 /PRNewswire via COMTEX/ -- CryoLife, Inc., CRY +2.52% , a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed read more HERE.

A keratin biomaterial gel hemostat derived from human hair: evaluation in a rabbit model of lethal liver injury.

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Thu, 27 Oct 2011 21:32:00 +0000

Abstract

Effective hemostatic dressings that are compatible with tissues are needed. Keratins are a class of biomaterials that can be derived by extraction of proteins from human hair. We have recently discovered that keratin biomaterials have hemostatic characteristics and hypothesize that a keratin hydrogel having the ability to absorb fluid and bind cells may be an effective hemostat. The goal of this study was to test a keratin hydrogel and evaluate it compared to current hemostats. Thirty-two New Zealand white rabbits received a lethal liver injury. Eight animals each were assigned to negative control, QuickClot, HemCon bandage, and keratin treatment groups. Vital stats and other data were recorded during surgery and all surviving animals were sacrificed after 72 h. Histology was conducted on all surviving animals. Twenty-four-hour survival rates were 0%, 62.5%, 62.5%, and 75% for the negative control, QuickClot, HemCon, and keratin groups, respectively. Other outcomes included blood loss, mean arterial pressure, heart rate, shock index, and liver histology. All of the hemostats were statistically better than the negative control group at late operative time points. The keratin group consistently performed as well as, or better than, the commercial hemostats. Histology showed an interesting healing response at the hemostat-liver interface in the keratin group.

Surgeons get tips and tricks for contending with antiplatelet therapy

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 12 Oct 2011 22:39:00 +0000

Lisbon, Portugal - A session on the best practice for operating on patients taking antiplatelet therapies was well received at the European Association for Cardio-Thoracic Surgery (EACTS) 2011 Annual Meeting this week, with attendees saying they welcomed advice on this topic in light of the newer antiplatelet agents coming onto the market.
Surgeons generally want to stop antiplatelet therapy several days before an operation to reduce bleeding risk, but this can have a negative impact in terms of thrombotic events, particularly if a patient has recently had a drug-eluting stent (DES) placed. And while there are recommendations for when to stop antiplatelet therapy prior to surgery—generally advised at five days beforehand for clopidogrel, three days for ticagrelor, and seven days for prasugrel—"the reality is that very often we have to proceed with surgery much faster," surgeon Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands) told the meeting.

Cardiologist Dr Freek Verheugt (Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands) acknowledged that "the eternal difficulty for the surgeon is balancing the risks of bleeding and thrombosis," in a sentiment that was echoed in another talk on "tips and tricks for operating under antiplatelet therapy," given by Dr Miguel Sousa Uva (Hospital da Cruz Vermelha Portuguesa, Lisbon).

Both Verheught and Sousa Uva stressed that the key to determining what to do about dual antiplatelet therapy in the face of surgery is to use individual risk assessment, on a case-by-case basis, and they advised using an algorithm to aid in this decision, taken from the latest European guidelines on revascularization.

Following the session, cochair Dr Jose Luis Pomar (Hospital Clinico de Barcelona, Spain) observed: "This is a very interesting topic. After this, I believe we are still ignorant, but perhaps we have a bit more understanding than before."

Fibrinogen and Hemostasis: A Primary Hemostatic Target for the Management of Acquired Bleeding

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Mon, 03 Oct 2011 23:52:00 +0000

Jerrold H. Levy, MD, FAHA,
Fania Szlam, MMSc,
Kenichi A. Tanaka, MDand
Roman M. Sniecienski, MD

+Author Affiliations
From the Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, Georgia.
Address correspondence to Jerrold H. Levy, MD, FAHA, Department of Anesthesiology, Emory University School of Medicine, Cardiothoracic Anesthesiology and Critical Care, Emory Healthcare, Atlanta, GA.

Abstract

Fibrinogen plays several key roles in the maintenance of hemostasis. Its cleavage by thrombin and subsequent polymerization to form fibrin strands provides the structural network required for effective clot formation. During cases of acute blood loss, attempts to maintain circulating volume and tissue perfusion often involve the infusion of crystalloids, colloids, and red blood cells. Intravascular volume resuscitation, although vital, frequently results in dilution of the remaining clotting factors and onset of dilutional coagulopathy. In such cases, fibrinogen is the first coagulation factor to decrease to critically low levels. There currently is a lack of awareness among physicians regarding the significance of fibrinogen during acute bleeding and, at many centers, fibrinogen is not monitored routinely during treatment. We reviewed current studies that demonstrate the importance of considering fibrinogen replacement during the treatment of acquired bleeding across clinical settings. If depleted, the supplementation of fibrinogen is key for the rescue and maintenance of hemostatic function; however, the threshold at which such intervention should be triggered is currently poorly defined. Although traditionally performed via administration of fresh frozen plasma or cryoprecipitate, the use of lyophilized fibrinogen (concentrate) is becoming more prevalent in some countries. Recent reports relating to the efficacy of fibrinogen concentrate suggest that it is a viable alternative to traditional hemostatic approaches, which should be considered. The prospective study of fibrinogen supplementation in acquired bleeding is needed to accurately assess the range of clinical settings in which this management strategy is appropriate, the most effective method of supplementation and a comprehensive safety profile of fibrinogen concentrate used for such an approach.
Accepted July 11, 2011.

Study: Kids Given Plasma Despite No Clear Benefit

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Sat, 01 Oct 2011 03:53:00 +0000

Many kids get plasma transfusions when there's little evidence they do much good, according to a new study.
Transfusions of so-called fresh frozen plasma are sometimes given to both kids and adults whose blood has problems clotting, or if they have lost a lot of blood from surgery or an accident.
But only a couple of studies in kids have shown that plasma transfusions are a good option for one specific heart surgery procedure. The rest of the time, researchers have found they don't work, or that their benefit is uncertain.
In the current study, pediatricians reported that almost three percent of kids admitted to children's hospitals in the U.S. had a transfusion. More than half of the transfusion recipients were under a year old, a third had heart disease and 70 percent were critically ill.
"For all we know, it may be used entirely appropriately," said Dr. John Puetz, from Saint Louis University, who worked on the study.
"The problem is, we don't have the evidence base... to demonstrate what's inappropriate use and what's not inappropriate use."
"The concern," he told Reuters Health, "is a fair number of children are being exposed to (fresh frozen plasma) without published data showing what it's effective for."
The problem with that, researchers said, is that the transfusions always come with a risk of side effects and complications, which range from allergic reactions to heart failure, if doctors give kids more plasma than their hearts can handle.
Puetz's team consulted a database of about 3.2 million admissions to 40 different children's hospitals in the last decade. According to hospital records, just under three percent of those kids got a plasma transfusion, most in the intensive care unit.
The researchers couldn't tell why the plasma was used in each case, or how much of it kids got. But only about one-third of the kids' records also showed they had a heart procedure known as a cardiopulmonary bypass -- when a pump does the job of the heart and lungs during surgery, and a plasma transfusion (along with red blood cells) is indicated.
There were 24 recorded cases of acute lung injuries related to the transfusions, but the authors write in the Journal of Pediatrics that it's hard to tell how many kids had other complications.
"The biggest reason not to give any transfusion... is the risk of the complications that you can have," said Dr. Lorne Holland, of the Nashville-based pathology services company PathGroup, Inc., who has researched the use of fresh frozen plasma. That would include lung injuries and congestive heart failure, as well as more minor itchy allergic reactions.
Still, Puetz added, "No one's really looked to see what all the possible side effects may be."
A typical plasma transfusion would cost a few hundred dollars, Holland said.
He thinks that too many kids are still getting the transfusions, despite the general lack of evidence that they work -- or are better than other alternatives such as whole-blood transfusions in certain cases.
"I think the numbers in that study and ones in adults are too high," Holland, who was not involved in the study, told Reuters Health. "A lot of physicians are convinced by evidence of, 'That one patient, that one time, seemed to do better when I gave it to them.'"
Puetz said it's still not clear whether plasma transfusions are being done too often, based on the lack of data. He called for more critical studies to see if fresh frozen plasma transfusions really do work in all of the cases where they're commonly used in kids.

Scientists Use Stem Cells for Blood 'Self-Transfusion'

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Fri, 02 Sep 2011 20:49:00 +0000

Researchers report that they used stem cells to create cultured red blood cells and then successfully injected the blood cells back into the human donor who provided the stem cells in the first place.
The findings raise the possibility of creating individualized blood supplies without making people donate their own blood for storage before they need a transfusion, a potentially dicey situation if someone is ill.
The researchers said that the cultured red blood cells created with the help of stem cells from the donor -- and then inserted back into the donor -- lived about as long as regular blood cells normally do.
The study, the first to show that red blood cells created from stem cells can survive in the human body, is "a major breakthrough for the transplant community," Dr. Luc Douay, senior study author and a professor of hematology at Universite Pierre et Marie Curie in Paris, said in a news release from the American Society of Hematology.
"There is a dire need for an alternative source of transfusable blood products, especially with the risk of infection from emergent new viruses that comes with traditional transfusion," Douay explained. "Producing red blood cells in culture is promising since other efforts to create alternative sources have not yet been as successful as once hoped."
However, one expert said the research isn't quite as exciting as it may sound.
Creating red blood cells from your own stem cells is "going to be an extremely complex process, extremely expensive, not very convenient and uncommonly used," explained Dr. Paul Holland, a blood banking specialist and a clinical professor of medicine and pathology at the University of California, Davis Medical Center.
"Most people who need a transfusion need it now, and they use blood from donors that's already there," he said. One exception might be if someone has a condition that makes it difficult to match his or her blood to other donors and it's dangerous to draw and save their own blood, he said.
The findings appear in the Sept. 1 issue of the journal Blood.

Cook Endoscopy Recalls Disposable Hemostasis Clips for Gastroenterologists

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 31 Aug 2011 21:45:00 +0000

Cook Endoscopy is recalling its Disposable Hemostasis Clip, DCH-7-230, according to a Total Recall report.

The company warned that the disposable clip may not deploy after being positioned inside the patient.

The device is used for endoscopic marking, hemostasis for mucosal sub-mucosal defects less than 3cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm wide and polyps less than 1.5 cm in diameter in the GI tract.

Baxter Announces FDA Approval of ARTISS Fibrin Sealant for Use in Face-Lift (Facial Rhytidectomy) Procedures

noreply@blogger.com (hemostatguy@gmail.com (hemostat guy)) — Wed, 31 Aug 2011 21:42:00 +0000

DEERFIELD, Ill., Aug 31, 2011 (BUSINESS WIRE) -- Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has expanded the indication of ARTISS [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift). ARTISS is the only premixed, ready-to-use fibrin sealant specifically indicated for tissue adherence in facial rhytidectomy (face-lift) and burn surgeries. It was first approved by the FDA in 2008 to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations one year of age or older.