Boston Scientific Snags Expanded Labeling FDA Nod for LAAC Device
With the update in labeling, the WATCHMAN FLX Device now includes a DAPT option.
Boston Scientific Corporation today announced it has received FDA approval to expand the instructions for use in labeling the current-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device to include a 45-day dual anti-platelet therapy (DAPT) option. This is an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation (NVAF). The labeling will help provide physicians more flexibility in choosing treatments determined to be most appropriate and give additional freedom for physicians to exercise their clinical judgement.
"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," said Dr. Ian Meredith, global chief medical officer, Boston Scientific. "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 WATCHMAN FLX Device is indicated for use in reducing the risk of thromboembolism from left atrial appendage in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for anticoagulation therapy. Additionally, the device is indicated for those deemed by their physicians as suitable for anticoagulation therapy and have an “appropriate rationale to seek a non-pharmacologic alternative to anticoagulation therapy, taking into account the safety and effectiveness of the device compared to anticoagulation therapy.”
Data given to the FDA in support of the labeling update included analyses spanning approximately 8,300 patients from the Left Atrial Appendage Occlusion Registry (LAAO Registry) within the American College of Cardiology Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR). The clinical evidence was submitted to demonstrate the safety and efficacy of DAPT as a post-procedural antithrombotic regimen in patients with NVAF who are seeking an alternative to OAC.
The choice of either OAC or a DAPT post-procedural drug regimen for WATCHMAN technology has been available in Europe since 2017.
Additionally, Boston Scientific reported recent clinical data supporting the WATCHMAN FLX device, including results from a recent analysis of more than 17,000 patients from the NCDR-LAAO Registry. The real-world data demonstrated no significant difference in rates of major adverse events (AEs) at 45-days post-implant no matter whether patients were discharged from the hospital on DAPT, a direct OAC and aspirin, or warfarin and aspirin.
SURPASS study clinical data was also recently presented. The study, which involved more than 16,000 patients from the NCDR-LAAO Registry, showed low rates of AEs and peri-device leak through 45-days post-implant. The Seal-FLX (NCT03399851) study comparing the WATCHMAN FLX device vs. the Amplatzer Amulet device indicated a significantly higher rate of complete occlusion of the left atrial appendage at eight weeks with the WATCHMAN FLX technology (72. 6% vs. 30.5%). This was evaluated by contrast enhanced cardiac CT imaging. The single-center retrospective study of 300 patients also demonstrated that median peri-device leak area, characterized as residual flow around the device from the LAA, was significantly smaller than the Amulet device.
Of note, there are two ongoing studies of the WATCHMAN FLX device that are evaluating use in broader patient populations with NVAF, CHAMPION-AF (NCT04394546) and OPTION (NCT03795298).
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