Boston Scientific gets FDA nod for long-lasting implantable cardiac devices Print E-mail
By Staff and Wire Reports   
Wednesday, 30 November 2011 09:33
FDA approvalBoston Scientific Corporation (Nasdaq:BSX) has announced the FDA approval of its INCEPTA(TM), ENERGEN(TM) and PUNCTUA(TM) cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) to treat heart failure and sudden cardiac death.

The new devices are said to offer enhanced therapy options, advanced battery longevity and a DF4 universal connector system in the industry's smallest and thinnest platform. The first implant of the Company's next-generation INCEPTA ICD occurred yesterday at the University of Washington Medical Center in Seattle.

"Boston Scientific is providing physicians a choice of premium high-energy devices that are the world's smallest and thinnest, offer advanced battery technology with excellent longevity, and are backed by the longest warranty in the industry of up to 10 years," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Cardiac Rhythm Management Group. "This new portfolio of products, built on our tradition of innovation, will provide physicians with flexible therapeutic options designed to match specific patient needs."

"These devices are a direct response to what patients tell us they want the most -- small, thin, long-lasting devices that provide appropriate therapy when necessary," said Dr. Poole. "Additionally, these devices are designed to streamline the implant procedure with Boston Scientific's 4-SITE(TM) DF4 connector system."

"The DF4 connector system makes the industry's smallest devices even smaller, potentially increasing patient comfort and making the implant procedure quicker and easier for physicians, while the new features will offer even more options for customizing patient care," said Kenneth Stein, M.D., Chief Medical Officer of Boston Scientific's Cardiac Rhythm Management Group. "The 4-SITE lead is built on the RELIANCE® family of defibrillation leads, which has a demonstrated survival probability of 99 percent at seven years."

Last week, there was an insider buy transaction at BSX.  Director Mario Ernest who bought 25,000 shares, increasing his holdings to 306,004 shares. Mr. Ernest has been a Director of BSX since 2001. Looking ahead via the BioMedReports FDA Calendar and World Wide Regulatory Catalyst Calendar, we have been tracking that in Japan, the company is expecting approval for the Taxus Element Stent System in late 2011 or early 2012 and for the Promus Element Stent System in mid 2012. 

Boston Scientific Corporation's business groups include: cardiology, rhythm and vascular group; endoscopy division; urology and women's health division; and neuromodulation division. Its cardiology, rhythm and vascular group's practice areas include: interventional cardiology - diagnose and treats coronary artery disease and other cardiovascular disorders; cardiac rhythm management - treats irregular heart rhythms and heart failure, and protect against sudden cardiac arrest; and the endovascular unit - encompasses product lines in the areas of peripheral interventions, neurovascular, imaging and electrophysiology. The company's endoscopy division's practice areas include: gastroenterology and pulmonary. Its urology/women's health division develops and manufactures devices to treat various urological and gynecological disorders. The company's neuromodulation business markets the Precision® Spinal Cord Stimulation (SCS) system, used for the management of chronic pain.




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