Boston Scientific (NYSE:BSX) is touting 12-month results from a trial assessing its next-generation Watchman left atrial appendage closure (LAAC) device.
Results from the Pinnacle FLX trial were published in Circulation and highlighted the safety and efficacy of Watchman in stroke prevention for patients with non-valvular atrial fibrillation (NVAF).
The 400-patient study observed Watchman FLX as an alternative to oral anticoagulation therapy, which includes non-vitamin K oral anticoagulants. It met its primary safety endpoint of occurrence of a major procedure-related complication within seven days following the procedure, registering a low adverse event rate of 0.5%.
Additionally, the trial met its primary effectiveness endpoint as the data demonstrated a 100% rate of effective LAAC at 12 months post-procedure.
Implant success tallied a rate of 98.8% and no patients experienced peri-procedural death, device embolization or pericardial effusion requiring cardiac surgery. Finally, 96.2% of patients were able to discontinue oral anticoagulation following their 45-day follow-up.
The study’s secondary endpoints, including the occurrence of ischemic stroke or systemic embolism, are set to be reported this year once 24 months of patient follow-up has been reached.