Boston Scientific (NYSE: BSX) today announced positive 24-month results from a trial evaluating its Watchman FLX left atrial appendage closure device.
Boston Scientific’s Watchman FLX LAAC, based in Marlborough, Mass., For patients with non-valvular atrial fibrillation (NVAF) has already proven its safety and efficacy in 12-month data from the same trial presented in April.
The latest data, presented as cutting edge clinical science at TVT: The Structural Heart Summit, evaluated Watchman FLX as an alternative to long-term oral anticoagulant therapy, including non-vitamin K antagonist oral anticoagulants (NOACs) for reducing the risk of stroke in patients with NVAF, according to a press release.
Pinnacle FLX, a 400-patient trial in the United States, met its secondary efficacy endpoint, having already met primary safety and efficacy endpoints in 12-month baseline data of this year. Watchman FLX met the endpoint, defined as the occurrence of ischemic stroke or systemic embolism over 24 months, with a rate of 3.4% against the performance target of 8.7% .
In addition, 24-month data demonstrated that no patient had undergone device embolization or pericardial effusion requiring cardiac surgery, which Boston Scientific says is favorable in the context of clinical studies. previous ones.
Watchman FLX obtained FDA approval in July 2020, having already obtained CE mark approval in Europe in March 2019. The next generation device is used in almost all American and European implants in place of the previous version, the company said.
“The final results of this pivotal study highlight how advancements in the Watchman FLX device design – which allow for improved anchorage, faster and more efficient LAA closure, and compatibility with more complex anatomies – resulted in an optional safe, effective and long-lasting for patients with NVAF at increased risk for stroke and systemic embolism and an appropriate rationale to seek a non-pharmaceutical alternative ”, Boston Scientific Global Medical Director Dr. Ian meredith mentionned in the output.