While the laparoscopic adjustable gastric banding (LAGB) procedure has been around for close to 10 years in the U.S. and 18 years worldwide, concerns have been raised in recent years regarding the safety and efficacy of the Lap-Band adjustable gastric banding system, made by Allergan (Irvine, California), specifically with respect to average weight loss and complications. Perhaps those concerns will be put to rest now that two new studies published in the current issue of Surgery for Obesity and Related Diseases, a peer-reviewed journal, support the Lap-Band system as a safe and effective weight-loss procedure. (Medical Device Daily)
The FDA has approved a new spine sealant, the DuraSeal Exact, from Covidien (Mansfield, Massachusetts). The company describes the product as a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The dura mater, or dura, encompasses the three layers of the meninges surrounding the spinal cord that protect and hold cerebrospinal fluid, Covidien noted. (Medical Device Daily)
Endo Pharmaceuticals (Chadds Ford, Pennsylvania) has agreed to shell out $2.9 billion in cash to acquire American Medical Systems (AMS; Minnetonka, Minnesota). The purchase price, $30 a share, includes the assumption and repayment of $312 million of AMS debt. The combined company will be positioned to deliver more comprehensive healthcare solutions across its businesses in branded pharmaceuticals, generics and devices and services, in the areas of urology and pain, Endo and AMS said. (Medical Device Daily)
A non-surgical device that creates a barrier between food and the intestine wall continues to prove its worth as a promising primary therapy for Type 2 diabetes and obesity, according to recently presented study data. (Medical Device Daily)
A new medical device company has emerged with the goal of targeting the $2 billion orthopedic trauma market with the industry's first line of high-quality generic implants and instruments. (Medical Device Daily)
NEW ORLEANS – Results of two company-funded studies clinical studies presented at the American College of Cardiology (ACC; Washington) meeting in the Big Easy this week demonstrate that the Resolute drug-eluting stent (DES) from Medtronic (Minneapolis) provides a positive and persistent treatment effect for a wide variety of patients with coronary artery disease. (Medical Device Daily)
NEW ORLEANS — Frail, elderly patients with aortic stenosis who underwent a transcatheter aortic valve replacement (TAVR) procedure had about the same survival at one year as similar patients who had conventional open-heart surgery. But the TAVR patients were also more likely to have a stroke following the procedure, according to highly-anticipated preliminary data presented Sunday at American College of Cardiology's (ACC; Washington) 60th annual scientific session. (Medical Device Daily)
