Medical Product Guide» | Medical Product Guide Blog

GlaxoSmithKline Receives Okay From FDA For Lamictal

Jim Marino — Tue, 02 Feb 2010 04:54:26 +0000

The FDA has approved GlaxoSmithKline’s Lamictal XR extended-release tablets as once-a-day, add-on therapy for epilepsy in patients over 13 years of age suffering from primary generalized tonic-clonic seizures. Lamictal XR is already approved for partial onset seizures for patients in this age group.

The study depicted that the addition of Lamictal XR in therapy reduced the seizure frequency more than placebo in patients with uncontrolled primary generalized tonic-clonic seizures.

A Novel Brain-based Computational Model Of How Parkinson’s Disease And Dopamine Medications Affect Learning And Attention

Jim Marino — Mon, 25 Jan 2010 06:36:35 +0000

A new brain-based computational model is helping to understand how Parkinson’s disease and dopamine medications – used to treat motor symptoms caused by the disease – can affect learning and attention. As reported in a forthcoming article in the Journal of Cognitive Neuroscience, a new computational model, at the Center for Molecular and Behavioral Neuroscience at Rutgers University, Newark, has shown how Parkinson’s disease affects attentional performance during learning.

For the full story, Click Here

TetraLogic Pharmaceuticals Initiates Phase 1 Clinical Trial Of TL32711 In Patients With Refractory Solid Tumors Or Lymphoma

Jim Marino — Mon, 18 Jan 2010 15:30:57 +0000

TetraLogic Pharmaceuticals announced that the Company has completed dosing of the first cohort in a Phase 1 clinical trial of its selective SMAC mimetic, TL32711. The Phase 1 trial is an open-label, dose-escalation study evaluating the safety and tolerability of TL32711 in adults with solid tumors or lymphoma refractory to standard therapies. The study will also assess the pharmacokinetics, pharmacodynamics and anti-tumor activity of TL32711.

For the full story, Click Here

Microlife’s WatchWT MedGem(R) Device Will Be Used To Assess Metabolic Changes In The Biggest Loser™ Contestants

Jim Marino — Tue, 12 Jan 2010 05:48:59 +0000

Microlife Medical Home Solutions, Inc. has announced The Biggest Loser medical staff will implement the MedGem indirect calorimeter to assess metabolic changes in program contestants. The MedGem handheld indirect calorimeter is an FDA-cleared, Class II, medical device that assesses metabolic rate by measuring a patient’s resting oxygen consumption. Resting metabolic rate varies dramatically between individuals. Until recently, most healthcare providers would estimate RMR using complicated estimation equations.

For the full story, Click Here

New “Scarless” Thyroid Surgery

Jim Marino — Mon, 11 Jan 2010 18:48:24 +0000

Dr. Emad Kandil of Tulane University School of Medicine is one of the first in the country to perform a new form of endoscopic surgery that uses a small incision under the arm to remove all or a portion of the thyroid or parathyroid glands without leaving a scar on the neck. Not only is Dr. Kandil one of the few surgeons in the US trained to perform the surgery, but he chairs an annual symposium at Tulane to teach surgeons how to perform minimally invasive thyroid surgery and will be teaching the technique to doctors from across the country.

Traditional surgery usually involves a fairly long incision at the base of the neck. The new Robotic transaxillay approach means that the patient won’t have a scar on the neck, and for many people, this is enough to try this novel technique.

Robotic gasless transaxillary thyroidectomy is a newly developed minimally invasive surgical technique to remove all or part of the thyroid. This was developed by Dr. Chung in South Korea. With this new technique, a small incision is made under the arm. Before its development, there were different options for thyroid surgery: conventional open surgery, endoscopic surgery with a shorter neck incision or transaxillary approach with gas insufflation. Conventional open surgery involves a scar on the neck. Endoscopic or videoscopic techniques are done using a small camera, however, this still involves a neck scar. The neck scar is shorter in these approaches, but still there is an incison in the neck. With the new method, there is no scar on the neck whatsoever.

Robotic gasless transaxillary thyroidectomy eliminates the neck scar by accessing the thyroid gland through a hidden incision under the arm. The special designed robotic arms allow the surgeon to operate with very precise movements. Robotic instruments do work just like hands. However, they are amazingly small. The robot is completely under the control of the surgeon. The robotic system also proides 3D visualization, with a special designed high-definition camera with an excellent magnification of 10x.

This technique is not only about avoiding an incision and a scar on the neck. From a surgical standpoint, safely performing these procedures depends on clear visualization of important nearby structures, including nerves and parathyroid glands.

Initially, robotic approach was done with gas insufflation to the neck area, however this gas can be retained, which can cause retained pneumomediastinum or subcutaneous air with uncomfortable crepitations. The patient may experience significant metablic problems with CO2 retention. The gas eventually will be absorbed, but it can cause siginificant discofort until this completely absorbed. These patients needed to stay hospitalized longer than they used to with conventional surgery for observation. With this new approach, gas insufflations is avoided, so Co2 retention complications are also avoided.

This procedure was recently approved by FDA and is is proven to be a safe approach. However, special training and experience with robotic surgery is a must to proceed. With more experience, more patients can be offered this approach. Large thyroid nodules over 4cm were initially not candidates for this procedure before, however, now the surgery is able to be offered to these patients with an excellent outcome.

Switching To Letrozole Helps Breast Cancer Patients With Anastrozole-Related Rheumatologic Symptoms

Jim Marino — Mon, 04 Jan 2010 11:56:17 +0000

Postmenopausal women with hormone receptor-positive (HR+) breast cancer who develop arthralgia and/or myalgia (A/M) while being treated with anastrozole may want to consider a switch to letrozole therapy, researchers said at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Women who experienced greater than equal to grade 2 A/M while receiving anastrozole and switched to letrozole developed significantly less A/M and had an improved quality of life compared with baseline.

For the full story, Click Here

ConvaTec Canada Launches Hydrofiber(R) Technology Web Site

Jim Marino — Mon, 28 Dec 2009 06:56:54 +0000

ConvaTec has announced the launch in Canada of a new web site, www.Hydrofiber.ca, demonstrating how the company’s proprietary Hydrofiber(R) Technology is transforming wound care. Designed for clinicians managing chronic and acute wounds, the web site illustrates the unique features and benefits of Hydrofiber(R) Technology with extensive video, data and commentary from research scientists within ConvaTec Wound Therapeutics. This transformational technology, unique to ConvaTec, powers the performance of advanced wound care products.

For the full story, Click Here

Cohera Medical Treats First Patient in Clinical Study of TissuGlu(R) Surgical Adhesive

Jim Marino — Mon, 21 Dec 2009 11:16:02 +0000

Cohera Medical Inc. has announced the treatment of the first patient in a study of its lead surgical adhesive product, TissuGlu®. The clinical investigation is a prospective, open-label, randomized study to investigate the safety of TissuGlu and its effect on wound drainage and associated complications in abdominoplasty, or “tummy tuck,” surgeries. The study will compare standard wound closure techniques to standard wound closure techniques plus the application of TissuGlu in 40 patients.

For the full story, Click Here

Synergetics USA to Market Disposable Bipolar Forceps Partner Agreement with Codman & Shurtleff.

Jim Marino — Mon, 14 Dec 2009 12:32:30 +0000

Synergetics USA, Inc. has announced the signing of an addendum to its three year agreement with Codman & Shurtleff, Inc. Under the terms of the revised agreement, Codman will have the exclusive right to market and distribute a Spetzler-Malis branded disposable bipolar forceps produced by Synergetics. This arrangement supports their ongoing efforts to reduce commercial expenses associated with our neurosurgery product lines.

Platinum-based coronary stent awarded CE Mark

Jim Marino — Mon, 07 Dec 2009 15:12:46 +0000

A new platinum-based stent, designed by Boston Scientific, has received its CE Mark and will now be available in the relevant countries. The PROMUS Element Everolimus-Eluting Coronary Stent System was granted approval by the Dutch notified body KEMA Quality BV. In addition to featuring a platinum chromium alloy designed specifically for coronary stenting, the system has an innovative stent structure and an impressive catheter delivery mechanism.