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Boston Scientific Up on FDA Nod for WATCHMAN Device - Analyst Blog

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Shares of medical device major Boston Scientific CorporationBSX jumped 3.8% to close at $17.24 yesterday, subsequent to the company's receipt of the U.S. Food and Drug Administration (FDA) approval for its well acclaimed WATCHMAN Left Atrial Appendage (LAA) Closure heart implant device.

This FDA approval validates the company's tireless efforts in developing ground-breaking medical technologies to diagnose and treat patients with coronary artery disease and other cardiovascular disorders.

The WATCHMAN device is basically a first-of-its-kind catheter-delivered heart implant that blocks the LAA in patients with atrial fibrillation (AF), so that migration of blood clots from the LAA can be averted. This device provides an alternative unique therapy to conventional long-term warfarin therapy - used to reduce the risk of blood clotting from the LAA in AF patients.

This WATCHMAN device is the first to be studied in a randomized clinical trial as an alternative to warfarin. It is commercially available in CE Mark countries and in some other nations internationally. In the U.S., Boston Scientific has completed the 18 month follow-up PREVAIL trial and the final 5 year follow-up in the PROTECT AF trial to evaluate the safety and efficacy of the WATCHMAN device in patients with non-valvular AF versus long-term warfarin therapy.

Results from both these trials have demonstrated the superior clinical efficacy of the WATCHMAN device in treating patients with non valvular AF, who are more prone to ischemic stroke and systemic embolism, over traditional warfarin therapy.

According to management, 40% of patients who need to undergo warfarin therapy avoid it for numerous reasons. Boston Scientific's WATCHMAN device provides the much-needed breakthrough alternative treatment that can reduce the risk of stroke in AF patients better, while maintaining necessary levels of safety and effectiveness during the procedure.

Currently, the WATCHMAN is the leading device in percutaneous left atrial appendage closure globally and has been used in the treatment of more than 10,000 patients worldwide.

During full year 2014, Boston Scientific's WATCHMAN device experienced solid revenue growth of 30%.

Given the fact that approximately 2.5 million adults in the U.S. suffer from AF currently and the number is only expected to go up with the rise in aging population, we believe the aforementioned FDA approval for the WATCHMAN device stands a good chance to enhance the company's profit margins, going ahead.

Currently, the stock carries a Zacks Rank #3 (Hold). Some top-ranked medical products stocks are Abaxis, Inc. ABAX , LeMaitre Vascular, Inc. LMAT and Phibro Animal Health Corp. PAHC . All three stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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