BSX : Trial Data Show Safety & Performance Of WATCHMAN FLX Left Atrial Appendage Closure Device

(RTTNews) - Boston Scientific (BSX) said that 24-month results from the PINNACLE FLX clinical trial demonstrated the safety and performance of WATCHMAN FLX left atrial appendage closure device for patients with non-valvular atrial fibrillation or NVAF.

The study evaluated the WATCHMAN FLX device as an alternative to long-term oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants or NOACs, for stroke risk reduction in patients with NVAF.

The PINNACLE FLX trial included 400 patients in the U.S. with NVAF who were eligible for anti-coagulation therapy to reduce the risk of stroke but had appropriate rationale to seek a non-pharmaceutical alternative.

Following the positive 12-month results in which the trial met its primary safety and efficacy endpoints, the trial met its secondary effectiveness 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%.

In addition to the low rate of ischemic stroke, the data through 24 months also demonstrated that no patients experienced a device embolization or pericardial effusion requiring cardiac surgery, all of which is favorable in the context of previous clinical studies.

The WATCHMAN FLX device received U.S. Food and Drug Administration approval in July 2020 and CE Mark in March 2019, and is now used in nearly all implants in the U.S. and Europe in lieu of the previous-generation device.

The company said it continues its clinical research on the WATCHMAN FLX device for use in patients with NVAF via two large prospective, randomized controlled trials.