Boston Scientific’s Unique WATCHMAN Stroke Prevention Device FDA Approved (VIDEO)

We’ve been “watching the WATCHMAN” here at Medgadget for nearly a decade (see flashbacks below) as the stroke prevention device from Boston Scientific has been slowly proving itself. The big news now is that the WATCHMAN has finally just been approved by the FDA as an alternative to warfarin to help reduce strokes in patients with non-valvular atrial fibrillation.

The device is positioned within the left atrial appendage, acting as a filter that prevents thrombi from traveling toward the brain. The frame is made of Nitinol, a common shape memory alloy, and is available in five different sizes to match each patient’s own anatomy. It has ten anchors that make sure that it stays aligned and in place, while the PET mesh promotes the growth of endothelial cells.

Some more info on the indication and what led to the device approval, according to Boston Scientific:

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 FDA approval of the WATCHMAN Device is based on the robust WATCHMAN clinical program which consists of numerous studies, with more than 2,400 patients and nearly 6,000 patient-years of follow-up. 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.

Here’s an animation showing the implantation of the WATCHMAN:

Flashbacks: WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use…; JoVE Video: The WATCHMAN Left Atrial Appendage Closure Device…; Watching the Watchman…; Watching the Watchman (again)…; Watchman: Plug Up Heart to Prevent Strokes…; Still Watching the Watchman…

Source: Boston Scientific Corporation…