Marlborough, Mass.-based Boston Scientific’s Watchman FLX LAAC device for patients with non-valvular atrial fibrillation (NVAF) had previously proven its safety and efficacy in 12-month data from the same trial presented in April.
The latest data, presented as late-breaking clinical science at TVT: The Structural Heart Summit, evaluated Watchman FLX as an alternative to long-term oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs) for stroke risk reduction in patients with NVAF, according to a news release.
Pinnacle FLX, a 400-patient trial in the U.S. met its secondary effectiveness endpoint, having already met primary safety and efficacy endpoints in the 12-month data from earlier this year. Watchman FLX hit the endpoint, defined as the occurrence of ischemic stroke or systemic embolism over 24 months, with a rate of 3.4% compared to the performance goal of 8.7%.
Additionally, the 24-month data demonstrated that no patients experienced device embolization or pericardial effusion requiring cardiac surgery, which Boston Scientific said proves favorable in the context of previous clinical studies.
Watchman FLX won FDA approval in July 2020, having already garnered CE mark approval in Europe in March 2019. The next-generation device is used in nearly all U.S. and European implants in lieu of the previous version, the company said.
“The final results of this pivotal study underscore how design advancements of the Watchman FLX device – which allow for improved anchoring, a faster, more effective LAA closure and compatibility with more complex anatomies – have translated into a safe, effective and durable option 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 chief medical officer Dr. Ian Meredith said in the release.