Medtech Insight from Elsevier Business Intelligence

Big Data: Health Care’s Brave New World

r.neil@elsevier.com — Tue, 28 May 2013 00:05:00 -0400

Health care is in the midst of a major transformation as data becomes the focal point of vital decisions that will affect patient care and everything used to deliver that care. Just as other industries have found ways to utilize data analytics to turn “Big Data” into a cost savings and efficiency tool, so too is health care moving to embrace the potential of Big Data to both improve patient care and impact the bottom line.

Reinvigorating The Coronary Stent Market: Can Bioresorbable Scaffolds Do The Job?

m.thompson@elsevier.com — Tue, 28 May 2013 00:04:00 -0400

Bioresorbable coronary scaffolds could transform the coronary stenting market once they become widely available. But although there are more than a dozen companies developing these promising devices, there are still a number of unanswered questions – chief among them, how effectively they will compete against existing and upcoming next-generation durable stents, and how much of a price premium bioresorbable devices will be able to command.

Transoral GERD Devices: Riding Out The Road To Reimbursement

a.staylor@elsevier.com — Tue, 28 May 2013 00:03:00 -0400

With health care becoming increasingly data driven, third-party payors are requiring a higher level of evidence before making a positive coverage determination for a new technology or procedure. This has made the road to reimbursement much longer and tougher for device companies in general, and manufacturers of transoral devices for GERD are a prime example.

Spinal Diagnostics Companies Bring Precision

Tue, 28 May 2013 00:02:00 -0400

The current technologies for diagnosing spinal disease don’t consistently deliver what’s required of any medical diagnostic: good predictive value, high specificity, sensitivity, validity, reproducibility, and safety. This is a gap that several young, innovative companies have set out to fill.

Report From HRS: PROTECT AF Positive For Watchman

Tue, 28 May 2013 00:00:00 -0400

Boston Scientific is highlighting a secondary-endpoint analysis showing that the left atrial appendage closure device reduced all-cause death by 34%. The company plans to submit a PMA for the device by the end of the second quarter.

Ethicon Gains PMA For SEDASYS; Opens New Opportunity In GI Medicine

a.staylor@elsevier.com — Tue, 28 May 2013 00:00:00 -0400

Ethicon finally received FDA approval in May for its SEDASYS System, a computer-assisted personalized sedation system that allows physician-led teams to safely administer the anesthetic agent propofol during certain gastroenterology procedures, including colonoscopy. The approval opens up a whole new product category for the company with a market potential of 15 million procedures in the US alone.

InspireMD Advances Embolic Protection Stent Technology

tracyneilssien@yahoo.com — Tue, 28 May 2013 00:00:00 -0400

InspireMD Inc. is making progress with its proprietary emboli-trapping InspireMD Embolic Protection Stent (EPS) platform technology for use primarily in patients with embolic-risk acute coronary syndromes, such as myocardial infarction and saphenous vein graft coronary interventions.

Hospital Survey Sheds Light On New Era Of Accountable Care

tracyneilssien@yahoo.com — Tue, 28 May 2013 00:00:00 -0400

In Premier Inc.’s new survey, hospitals and health systems project a significant shift in 2013 admissions from inpatient to outpatient settings as these sites transition toward new care delivery models.

Medical Device Deals Update, May 2013

b.detuzzi@elsevier.com — Tue, 28 May 2013 00:00:00 -0400

Derived from Strategic Transactions, Elsevier Business Intelligence’s premium source for tracking life sciences deal activity, the Medical Device Deals Update column is a survey of recent medtech M&A, Alliance, and Financing activity.

Minimal Correlation To Device Costs In CMS-Released Hospital Charge Data

rebecca.kern@elsevier.com — Tue, 28 May 2013 00:00:00 -0400

An unprecedented release of data by CMS highlights vast differences across the country between what hospitals charge for different procedures, but the disparities by and large don’t reflect actual hospital costs.

Advanced Imaging Slowdown Significant Factor In Overall Health Spending Deceleration – Study

s.darcey@elsevier.com — Tue, 28 May 2013 00:00:00 -0400

Policymakers have cited the struggling economy as the primary source of the deceleration in overall health care spending, but an advanced imaging slowdown, lower prescription drug spending, and several other factors may have combined to play an even more significant role, Harvard economists argue.

AgPlus Diagnostics Ltd.

suzwriter@googlemail.com — Tue, 28 May 2013 00:00:00 -0400

AgPlus Diagnostics Ltd. has developed a rapid, handheld, low-cost diagnostic device that will deliver quantitative results within 10 minutes. Designed to work in both clinical and non-clinical settings, it uses a patented electrochemical immunoassay in a microfluidic chip to detect the test substance, combined with a read-out from charged silver nanoparticles, which increase the sensitivity of the test and allow the use of smaller samples than other diagnostic systems.

MitaMed Ltd.

bkronemyer@frontier.com — Tue, 28 May 2013 00:00:00 -0400

MitaMed Ltd.’s EndoVE allows for minimally invasive, non-thermal tumor ablation via the end of a standard endoscope. In conjunction with the delivery of a small dose of a chemotherapeutic, the device is placed at the tumor site, then delivers a series of eight, low-energy, electrical pulses directly to the tumor cells, increasing their porosity and thus boosting the absorption rate of the chemotherapy drug.

Medtech Execs On The Move, May 2013

rpaleski@att.net — Tue, 28 May 2013 00:00:00 -0400

Recent executive-level company changes and promotions in the medical device and diagnostics industries.

Glaucoma Devices: Progress On Multiple Fronts

Michael@LachmanConsulting.com — Fri, 26 Apr 2013 00:05:00 -0400

Recent progress on the US regulatory front is generating renewed interest in device-based glaucoma therapies, which potentially could grow to a multibillion-dollar industry. The list of companies targeting this space continues to expand, as does the variety of potential device-based solutions: the current pipeline includes several innovative and less invasive products and technologies designed to improve surgical outcomes, a growing number of advanced drug-delivery inserts to address the patient noncompliance issue that is so common in this arena, and some unique patient monitoring devices.

Emerging Peripheral Nerve Technologies Draw New Competitors To Neuromodulation Market

Fri, 26 Apr 2013 00:04:00 -0400

Emerging technologies in peripheral nerve stimulation are expected to play a pivotal role in opening up new markets and driving growth in the neuromodulation device market in the years ahead. As a result, the pipeline is rich with products designed to address a growing number of patients with long-term pain and other chronic conditions, many of whom have no other treatment options.

EVAR Update: Competitors Stake Their Ground In A High-Growth Space

m.thompson@elsevier.com — Fri, 26 Apr 2013 00:03:00 -0400

The endovascular abdominal aortic aneurysm repair (EVAR) market is one of the brightest growth opportunities in the medical device arena today. As a result, the competitive landscape is heating up as several new entrants stake their claim for a share of this $1+ billion opportunity.

Transcatheter Valves At The Tipping Point

tracyneilssien@yahoo.com — Fri, 26 Apr 2013 00:01:00 -0400

Although Edwards is the pioneer and market leader in TAVR, there is no shortage of competitors – in both the aortic and mitral valve segments – developing next-generation devices who would be happy with a fraction of this potential multibillion-dollar opportunity.

At AAOS Knee Implant Makers Pitch Better Fit, Precision

t.salemi@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

Once beyond reproach, knee replacement surgeries are getting a long, hard look by surgeons, researchers, and companies trying to determine whether success rates that exceed 90% can be improved upon by using customized implants or surgical robots.

Blood Test For Appendicitis Begins Pivotal US Trial

r.neil@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

Following a market launch in Europe, Venaxis Inc. is beginning a pivotal US clinical trial for a blood test to rule out appendicitis that potentially could change the way patients with abdominal pain are handled in hospital emergency rooms.

EarlySense Gains Patent For Respiratory Trending Analysis Designed For Reducing “Never Events”

a.staylor@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

In March 2013, EarlySense Ltd. gained a US patent for the respiratory trending analysis portion of its EarlySense System, a touch-free monitoring system that detects a patient’s heart rate, respiration, and movement using a sensor placed under the bed mattress. The company is initially targeting the estimated two million medical surgical beds in US and European hospitals in hopes of improving patient safety and reducing preventable adverse events.

New Surgical Tool Shines Light On Orthopedic Procedures

r.neil@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

Invuity has launched a new illuminated orthopedic surgical tool, adding to its growing line of devices that promise to provide surgeons with improved visibility in an era of smaller and smaller surgical incisions.

Medical Device Deals Update, April 2013

b.detuzzi@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

Medical Device Innovation Consortium Sets Priorities To Advance Regulatory Science

rebecca.kern@elsevier.com — Fri, 26 Apr 2013 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month: Heads of the newly formed private-public partnership comprising industry, academia, and FDA describe the group’s top three projects to advance medical device regulatory science.

Actium Biosystems LLC

bkronemyer@frontier.com — Fri, 26 Apr 2013 00:00:00 -0400

The Actium Cancer Treatment System from Actium Biosystems LLC is designed to improve bladder cancer treatment by selectively heating chemotherapeutic agents within the body to drive them more deeply into tumors. Studies confirm that as much as four times the amount of drug reaches the cancer tumor with the addition of hyperthermia, compared with the standard of care for chemotherapy that does not use any heat and thus treats at the normal body temperature.

MacuLogix Inc.

bkronemyer@frontier.com — Fri, 26 Apr 2013 00:00:00 -0400

The AdaptDx from MacuLogix Inc. has the potential to be the first practical diagnostic instrument for early detection of AMD. Akin to routine peripheral vision testing for glaucoma, the noninvasive desktop device measures impaired dark adaptation (the speed with which vision is recovered when moving from a brightly lit environment to darkness), an early-stage marker of AMD development.

Neuromodulation Market: Innovation Brings High-Growth Rewards

a.staylor@elsevier.com — Wed, 27 Mar 2013 00:05:00 -0400

Neuromodulation is one of the largest and fastest growing segments of the worldwide medical device market, with global revenues expected to reach $6 billion by 2020; as a result, the number of products in the neuromodulation pipeline is exploding. New and improved technologies will permit deeper penetration of neuromodulation therapies into existing patient groups as well as expansion of the market to new patient populations that could eventually number in the multi-millions.

Two Small Companies See Huge Opportunities In Heart Failure Device Space

m.thompson@elsevier.com — Wed, 27 Mar 2013 00:04:00 -0400

CardioKinetix, maker of a unique, percutaneously placed ventricular partitioning device, and CircuLite, which is developing a less invasive cardiac assist device, are moving into US clinical trials with their technologies – an important milestone for emerging companies in the difficult heart failure space. Both offer therapies aimed at helping fill the huge heart failure treatment gap that exists today.

High-Tech Solutions For Stroke Rehab

r.neil@elsevier.com — Wed, 27 Mar 2013 00:03:00 -0400

Clinicians who work with stroke patients are beginning to look at robotics and other innovative technologies in rehabilitation that could allow for more treatments without increasing staffing. Young companies with products in development compete with established players in this market, which eventually could become more important to providers as reform efforts move ahead.

Device Investors Showing Some Spine

m.stuart@elsevier.com — Wed, 27 Mar 2013 00:01:00 -0400

Elsevier’s Strategic Transactions shows that just in the last year, 26 spine or low back pain companies received private funding. To be sure, many were small rounds, some were funded with debt, and some were insider rounds trying to keep companies moving forward, but venture investors showed excitement by investing in large rounds for a select number of start-ups.

Will Watchman Prevail With FDA? Boston Scientific’s LAA Closure Trial Raises Questions, Controversy

Wed, 27 Mar 2013 00:00:00 -0400

The PREVAIL study of Boston Scientific’s Watchman left atrial appendage (LAA) closure device was primarily positive, but will it be enough to win FDA approval for the device?

Medtronic Marches Ahead In Renal Denervation; Announces Symplicity’s Inclusion In US Parallel Review Program

m.thompson@elsevier.com — Wed, 27 Mar 2013 00:00:00 -0400

Medtronic’s Symplicity renal denervation system has won entrance into an elite group – it is one of the first devices to be selected for the joint FDA/CMS parallel review program, launched in 2011. That distinction could help the company quickly move the device into US clinical practice once it’s FDA approved.

Robotic Hysterectomy: Procedures Increasing, But Questions Remain

tracyneilssien@yahoo.com — Wed, 27 Mar 2013 00:00:00 -0400

Controversy continues to swirl around robotic surgical procedures and this time the target is robotic hysterectomy. However, the drama does not seem to be impacting the number of these procedures performed robotically, a statistic that is clearly on the rise.

TissuGlu Surgical Adhesive Begins US Abdominoplasty Trial

tracyneilssien@yahoo.com — Wed, 27 Mar 2013 00:00:00 -0400

Abdominoplasty is one of the most common plastic surgery procedures performed today, but it requires the insertion of problematic drains to remove fluids at the surgical site. Cohera Medical believes its TissuGlu Surgical Adhesive is a better alternative that will speed healing and reduce complications – and the company is now collecting US randomized clinical data aimed at proving that claim.

Hospitals Closely Watching Manufacturers On Tax-Related Price Increases

r.neil@elsevier.com — Wed, 27 Mar 2013 00:00:00 -0400

As the medical device industry continues to fight for repeal of the newly implemented excise sales tax, hospitals’ group purchasing organizations have set up a web site to monitor manufacturers believed to be passing along the tax to hospital customers. Medtech Insight spoke with representatives from both the manufacturers’ and the GPOs’ respective trade associations.

Medical Device Deals Update, March 2013

b.detuzzi@elsevier.com — Wed, 27 Mar 2013 00:00:00 -0400

Washington Roundup, March 2013

Wed, 27 Mar 2013 00:00:00 -0400

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”

Device Trends To Watch In 2013

m.stuart@elsevier.com — Wed, 27 Feb 2013 00:05:00 -0500

The prospective medical device tax, the continuing decline of venture investing, pricing challenges, austerity measures in Europe, and other headwinds continued to push against the medtech industry in 2012. But emerging clinical and geographic markets, along with an active M&A market, are providing the industry with some momentum going into 2013.

Large Joint Replacement Market: Set For A Rebound?

m.thompson@elsevier.com — Wed, 27 Feb 2013 00:04:00 -0500

Beaten down by the great recession, the large joint arthroplasty market appears to be on the cusp of a turnaround, with several big players reporting encouraging Q4 and full-year 2012 results. A full recovery in this space is likely to take some time, but technology advances could help jumpstart the process, and there may be some interesting dynamics ahead in the patient-specific implant and robotic ortho device arenas.

Pressure Builds In Ventricular Assist Market

tracyneilssien@yahoo.com — Wed, 27 Feb 2013 00:03:00 -0500

With only two companies, Thoratec and HeartWare International, selling LVADs in the US, clinical data along with sales and product pipeline strategies have become paramount for capturing market share – and expanding the market to treat a wide range of class III heart failure patients.

Pioneering The New Mobile Health Paradigm: A Conversation With AliveCor’s David Albert, MD

r.neil@elsevier.com — Wed, 27 Feb 2013 00:01:00 -0500

A new, mobile monitoring technology has entered the cardiovascular market, and companies that already own a piece of the landscape are paying close attention to its debut. Start-up AliveCor Inc. has launched a heart rhythm monitor that works with smartphones – one of the first of a new breed of mobile medical devices that could have a disruptive impact on health care as it is performed today.

Entellus Launches New Sinus Treatment Device; Prepares To Release Data From Randomized Study

r.neil@elsevier.com — Wed, 27 Feb 2013 00:00:00 -0500

While launching a new balloon-based device to treat chronic sinusitis, Entellus Medical Inc. revealed it would release details on an important clinical study in July.

Ethicon Breaks New Ground With Articulating Laparoscopic Energy Device

a.staylor@elsevier.com — Wed, 27 Feb 2013 00:00:00 -0500

Ethicon hopes to increase penetration in the advanced energy market with its new ENSEAL G2 Articulating Tissue Sealer, a first-of-its-kind, articulating, laparoscopic energy device designed for use in complex procedures, including colorectal, thoracic, single-site, and cancer surgeries.

Novian Health Raises $11 Million Series A; Ramps Up Studies Of Breast Cancer Laser Ablation

m.thompson@elsevier.com — Wed, 27 Feb 2013 00:00:00 -0500

Novian Health Inc. will use its recent $11 million Series A round to kickstart multicenter clinical trials on its Novilase Interstitial Laser Therapy for ablating early-stage breast cancer.

Endovascular Thrombectomy Shows No Benefit Over Standard Of Care In MR RESCUE

re.miller@elsevier.com — Wed, 27 Feb 2013 00:00:00 -0500

A National Institutes of Health-sponsored trial appears to dash hopes that CT or MR imaging can help select patients for acute stroke treatment with first-generation thrombus retrieval systems.

Medical Device Deals Update, February 2013

b.detuzzi@elsevier.com — Wed, 27 Feb 2013 00:00:00 -0500

Washington Roundup, February 2013

Wed, 27 Feb 2013 00:00:00 -0500

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.”

CardioLogical Solutions: Combining Forces To Deliver A Range Of TAVI Accessories

bkronemyer@frontier.com — Wed, 27 Feb 2013 00:00:00 -0500

The recently announced merger of two innovative cardiovascular device companies – VasoStitch Inc. and Emboline Inc. – under the name CardioLogical Solutions promises to create a full range of accessory devices to improve the safety and efficacy of transcatheter aortic valve implantation (TAVI) procedures performed by either an interventional cardiologist or a thoracic surgeon.

Endo Tools Therapeutics SA: Enabling Natural Orifice GI Procedures

bkronemyer@frontier.com — Wed, 27 Feb 2013 00:00:00 -0500

Belgium-based Endo Tools Therapeutics SA is developing devices that will enable NOTES procedures to treat disorders such as type 2 diabetes, morbid obesity, and digestive tract tumors. Its Endomina device is a universal, multi-channel triangulation platform for use on any existing endoscope through the natural orifices, such as the esophagus.

Drug-Coated Balloons Fuel Multibillion-Dollar Hopes

m.thompson@elsevier.com — Wed, 30 Jan 2013 00:05:00 -0500

With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.