FDA approves Watchman LAAC device to reduce the risk of thromboembolism- Boston Scientific

Boston Scientific Corporation has received FDA approval for the Watchman Left Atrial Appendage Closure Device. 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 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 CHADS 2 or CHA 2DS2-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 clinical program provided strong evidence that the Watchman device can be implanted safely and reduces the risk of stroke in eligible patients while enabling most patients to discontinue warfarin. Additionally, a meta-analysis of all of the randomized trial data demonstrated that while ischemic stroke reduction favored warfarin, the Watchman device provided patients with a comparable protection against all-cause stroke and statistically superior reductions in hemorrhagic stroke, disabling stroke, and cardiovascular death compared to warfarin over long-term follow-up.

Comment; Watchman is a novel device introduced into the heart via a flexible tube (catheter) through a vein in the groin intended to close off the left atrial appendage. The device is designed to capture any clots that may form in the appendage, reducing the risk of stroke and potentially eliminating the need for long term use of blood thinning medications.Up to 40 percent of patients who are eligible for oral anticoagulation do not take it for numerous reasons, thus supporting the need for additional treatment options. Boston estimates the market for Watchman at about $500 million a year, and, it is currently the only product of its kind on the market in the US. St. Jude Medical started a pivotal trial for its similar Amplatzer Cardiac Plug, but is likely at least two years behind Boston Scientific