Watchman FLX Next Gen Stroke Prevention Device Now FDA Approved


Boston Scientific’s WATCHMAN, a device that’s used to close the left atrial appendage, has done wonders for preventing the formation of clots that lead to stroke in many patients. Now the company has announced that its WATCHMAN FLX, a new and much improved version of the implant, won FDA approval. Already cleared in the European Union, the WATCHMAN FLX is indicated for patients with non-valvular atrial fibrillation (NVAF) for whom oral anticoagulants are not sufficient.

The new minimally invasive implant can be recaptured, repositioned, and redeployed until proper placement is achieved, or removed if the procedure proves too challenging. A new frame helps to achieve a better seal with the tissue, thereby reducing the chance of blood coming in or out of the left atrial appendage and producing a thrombus. Overall, the fully rounded design helps to navigate the implant into place and five different sizes allow for a precise fit, as well as for a wider array of patients to be treated.

“We’ve been very pleased with the real-world clinical outcomes and positive physician feedback for the WATCHMAN FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the U.S.,” said Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific, in the announcement. “Our WATCHMAN technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide, and now with the WATCHMAN FLX device, we are taking the clinical benefits of the technology to the next level for more patients while further differentiating our structural heart portfolio in the U.S.”

Some results of a recent study of the WATCHMAN FLX, according to Boston Scientific:

Positive 12-month results from the pivotal PINNACLE FLX study, which evaluated the performance of the WATCHMAN FLX device as an alternative to long-term non-vitamin K antagonist oral anticoagulants (NOACs) and other OAC medications, were recently presented as a late-breaking clinical trial at Heart Rhythm Society 2020 Science. The study met its primary safety and efficacy endpoints with data demonstrating a low rate of major procedure-related safety events (0.5% at 7 days post procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm at 12 months post procedure). Data also demonstrated a high implant success rate of 98.8%.

Here’s a Boston Scientific promotional video for the WATCHMAN FLX:

Product page: WATCHMAN FLX

Flashbacks: Boston Sci’s Next Generation WATCHMAN FLX Stroke-Preventing Device Cleared in EU; Boston Scientific’s Unique WATCHMAN Stroke Prevention Device FDA Approved; WATCHMAN Left Atrial Appendage Closure Device Gets CE Mark for Expanded Use; Watching the Watchman (again)

Via: Boston Scientific

– Original Source link –