Boston Scientific won CE Mark approval and is reporting first implantations of its new WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device.
The implant is completely repositionable and removable, and is based on the original popular WATCHMAN, a device that’s been extensively used for LAAC procedures.
From the announcement:
This approval marks the second significant regulatory and commercial milestone for the Structural Heart business of Boston Scientific this year, following the U.S. Food and Drug Administration (FDA) approval of the first-generation WATCHMAN Device in March, 2015. In the U.S., the WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are deemed by their physicians to be suitable for warfarin, and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
Commercialization of the WATCHMAN FLX Device is currently in a limited market release and will become more widely available to approved EU countries in the first half of 2016. The WATCHMAN FLX Device is not available for sale in the U.S.
Source: Boston Scientific…