Boston Scientific’s Watchman FLX Evaluated in PINNACLE FLX Trial

April 6, 2021—Boston Scientific advised that 12-month results from the PINNACLE FLX trial were published online by Saibal Kar, et al online ahead of print in Circulation.

PINNACLE FLX is assessing the safety and efficacy of the company’s next-generation Watchman left atrial appendage closure device for stroke prevention in patients with nonvalvular atrial fibrillation. The 400-patient study evaluated performance of the Watchman FLX as an alternative to oral anticoagulation therapy, including nonvitamin-K oral anticoagulants.

The company noted that the manuscript provides further insights on primary patient outcomes after the initial late-breaking presentation of the 12-month data at HRS 2020 Science, the annual Heart Rhythm Society Scientific Sessions held as a virtual conference last May.

As outlined by Boston Scientific, highlights of the study findings reported in Circulation include:

• The primary safety endpoint—defined as occurrence of a major procedure-related complication within 7 days after the procedure—was met with a low adverse event rate of 0.5%.
• The primary effectiveness endpoint was met with a 100% rate of effective left atrial appendage closure at 12 months postprocedure with peridevice flow < 5 mm.
• The implant success rate was 98.8%.
• No patients experienced periprocedural death, device embolization, or pericardial effusion requiring cardiac surgery; findings that are favorable in the context of previous clinical studies.
• 96.2% of patients were able to discontinue oral anticoagulation after their 45-day follow up.

Secondary endpoints from the PINNACLE FLX study, including the occurrence of ischemic stroke or systemic embolism, will be reported this year after 24 months of patient follow-up, stated Boston Scientific.