Boston Scientific’s WATCHMAN FLX OK’ed for 45-Day DAPT

Boston Scientific received U.S. Food and Drug Administration (FDA) approval to expand the WATCHMAN FLX left atrial appendage closure (LAAC) device for 45-day dual anti-platelet therapy (DAPT) for post-procedural treatment of non-valvular atrial fibrillation (NVAF) patients.
 
45-day DAPT is an alternative to 45-day oral anticoagulation (OAC) plus aspirin for NVAF.
 
“This revised labeling provides physicians more flexibility to exercise their clinical judgment based on individual patient characteristics to determine the most appropriate post-procedural antithrombotic medication regimen,” Dr. Ian Meredith, global chief medical officer of Boston Scientific told the press. “This significant step forward is supported by the robust safety and efficacy profile demonstrated by both the legacy WATCHMAN and current-generation WATCHMAN FLX technologies.”
 
The FDA labeling update was supported by analyses of 8,300 patients from the LAAO Registry within the American College of Cardiology Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR). The data was submitted to support DAPT’s safety and efficacy as a post-procedural antithrombotic regimen in NVAF patients with a reason to seek an alternative to OAC.
 
Recent WATCHMAN FLX real-world data includes results of an analysis of over 17,000 patients from the NCDR-LAAO Registry that demonstrated no significant difference in rates of major adverse events at 45 days post implant, whether patients were discharged from the hospital on DAPT, a direct OAC and aspirin, or warfarin and aspirin.