Boston Scientific: FDA Okays WATCHMAN Left Atrial Appendage Closure Device

(RTTNews) - Medical device maker Boston Scientific Corp (BSX) on Friday said the U.S. Food and Drug Administration has approved the WATCHMAN Left Atrial Appendage Closure Device.

The company said the WATCHMAN Device offers a new stroke risk reduction option for high-risk patients with non-valvular atrial fibrillation who are seeking an alternative to long-term warfarin therapy.

The company said the WATCHMAN device will be made available to U.S. centers involved in its clinical studies and additional, specialized centers as physicians are trained on the implant procedure.

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.

The WATCHMAN Device has been commercially available internationally since 2009 and is a key device in percutaneous left atrial appendage closure globally, the company said.