Credit: Shutterstock photoShares of Boston Scientific CorporationBSX rose 1.4% to close at $17.87 on Friday, subsequent to the company's receipt of the CE Mark for its next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device - used to treat patients suffering from atrial fibrillation (AF).
Soon after this, the company announced the first implant of this second generation WATCHMAN device in Europe. Currently, the device has been released in limited European markets and will be more widely available to approved EU countries in the first half of 2016. However, it is not yet available for sale in the U.S. market.
Interestingly, this European commercialization approval marks the second significant regulatory and commercial milestone in 2015 for the Structural Heart business of Boston Scientific, following the U.S. Food and Drug Administration's (FDA) clearance of its first-generation WATCHMAN device in March.
Originally, Boston Scientific designed the first generation WATCHMAN device (which was awarded the full CE Mark in 2012) as a first-of-its-kind catheter-delivered implant that blocks the LAA in patients with non-valvular AF. This helps avert the migration of blood clots from the LAA. Per management, it is a proven alternative to long-term warfarin therapy for stroke risk reduction in patients with non-valvular AF.
Now with the availability of the second generation WATCHMAN FLX, physicians can reduce the risk of stroke for tens of thousands of high-risk patients with non-valvular AF, as a suitable alternative to long-term anticoagulant therapy. Per management, the unique features of this latest generation device make it suitable for implantation in a variety of patients with simple to the most complex anatomies.
Further, management plans to soon initiate a controlled product rollout of this second generation device to clinicians across Europe.
Impressively, in the U.S. market, the company has already witnessed successful implant rates and high quality patient outcome for the first generation WATCHMAN device. Management expects publication of an economic analysis in a major cardiology journal shortly, which will highlight the superiority of the WATCHMAN device over both warfarin and the novel oral anti-coagulants, in reducing healthcare cost in the long run while also providing outstanding results for patients.
We expect to witness similar results with respect to Boston Scientific's second-generation WATCHMAN implant in the European market, going forward.
Given the fact that approximately 2.7-6.1 million adults in the U.S. suffer from AF currently, and the number is only expected to go up with a rise in aging population, we believe the CE Mark approval for the next-generation WATCHMAN device will further the scope of enhancing the company's profit margins, going ahead.
Currently, the company carries a Zacks Rank #3 (Hold). Some better-ranked medical products stocks are GW Pharmaceuticals plc GWPH , Hill-Rom Holdings, Inc. HRC and ICU Medical, Inc. ICUI . All the 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.
