Medical device major Boston Scientific Corporation's (BSX) WATCHMAN Left Atrial Appendage Closure (LAAC) heart implant has received positive votes from the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee.
The panel's recognition of the WATCHMAN device as an appropriate treatment option for atrial fibrillation (AF) patients is expected to encourage Boston Scientific further in its research on heart-related complications.
The WATCHMAN Device is a catheter-delivered heart implant that blocks the left atrial appendage (LAA), so that the migration of blood clots from the LAA can be averted. This device retains the capability of minimizing the occurrence of stroke and systemic embolism for higher risk patients suffering from non-valvular AF. The device is commercially approved in more than 70 countries and so far 9,000 patients have been implanted with it globally.
Based on a favorable vote of 6 to 5 (with 1 abstention), the Panel deduced that derived benefits of the WATCHMAN device overshadow the potential risks associated with it. Moreover, going by the Panel's voting, there is a reasonable assurance of the safety and efficacy of the device.
Precisely speaking, the Panel members, after reviewing updated clinical evidence for the device, have acknowledged the fact that Boston Scientific's WATCHMAN device offers a long-desired substitute to long-term warfarin therapy for AF patients, who are more prone to stroke.
In the U.S., the WATCHMAN device is still in an investigational stage. Management is optimistic about winning the FDA go-ahead for the device in the first half of 2015. Given that the FDA gives substantial weightage to the Panel's recommendations, we expect the WATCHMAN device to gain the regulatory approval without much hurdle.
In the last reported quarter, this device delivered strong year-over-year growth of 30% outside the U.S. on a constant currency basis. With its U.S. approval expected next year, we look forward to solid growth in the device's demand in the domestic market as well, which will duly strengthen the company's structural heart franchise.
Currently, Boston Scientific carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), OraSure Technologies, Inc. (OSUR) and ZELTIQ Aesthetics, Inc. (ZLTQ). All three stocks sport a Zacks Rank #1 (Strong Buy).
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