The Marlborough, Mass.-based company describes the Watchman FLX as a permanent implant designed to close off the left atrial appendage and thus reduce the risk of stroke without the bleeding danger associated with blood-thinners. It is indicated for people who have atrial fibrillation that is not caused by a heart valve problem.
Boston Scientific touted the Watchman FLX as easier to implant, re-capturable and re-positionable. The device has a new frame design that allows for optimal engagement with the tissue for long-term stability and a faster, more complete seal, the company added. It received the CE Mark in Europe in March 2019.
Watchman FLX’s fully rounded design offers physicians the ability to safely enter, and maneuver within, the left atrial appendage, the company said. It is available in broader size options than the previous-generation device and can treat a wider range of patient anatomies.
“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 of Boston Scientific’s interventional cardiology division, in a news release. “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.”
Positive 12-month results from the pivotal PINNACLE FLX study, which evaluated the performance of the Watchman FLX 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 a high rate of effective LAAC (100% with peri-device flow < 5mm at 12 months post-procedure). The data also demonstrated an implant success rate of 98.8%.
The prospective, non-randomized PINNACLE FLX trial included 400 U.S. patients with nonvalvular atrial fibrillation (NVAF) who were eligible for anti-coagulation therapy to reduce the risk of stroke but had an appropriate rationale to seek a non-pharmaceutical alternative.
The Watchman FLX is also being studied in two other trials. The OPTION trial is comparing the device oral anticoagulants in NVAF patients who also undergo a cardiac ablation procedure. The CHAMPION-AF trial will study a broader OAC-eligible patient population in a head-to-head fashion to compare the device against NOACs.
The FDA approved the original Watchman in 2015. A long-term followup study on the device released in 2019 showed low risk of hemorrhagic stroke and a high percentage of patients who discontinued anticoagulation drugs at one year.
Boston Scientific said it will immediately begin a limited launch of the Watchman FLX in the U.S.
The company announced the FDA approval just before market close. Shares in BSX rose 2.05% to $38.25 in after-hours trading.