Boston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX™ LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option
Boston Scientific (NYSE: BSX) has received FDA approval to expand the labeling for its WATCHMAN FLX Left Atrial Appendage Closure Device. The update allows for a 45-day dual anti-platelet therapy (DAPT) option as an alternative to the existing oral anticoagulation (OAC) regimen for patients with non-valvular atrial fibrillation (NVAF). This change provides physicians with more treatment flexibility based on patient needs. Clinical data, including analyses of over 8,300 patients, supports the safety and efficacy of the DAPT regimen. The device demonstrated significant advantages in clinical trials, including higher rates of complete occlusion compared to competitors.
- FDA approval for WATCHMAN FLX expanded labeling for DAPT, enhancing treatment options.
- Clinical data supports the safety and efficacy of DAPT in over 8,300 patients.
- Demonstrated higher complete occlusion rates compared to Amplatzer Amulet device (72.6% vs. 30.5%).
- None.
WATCHMAN FLX now the only LAAC technology in the United States that allows for either DAPT or OAC immediately following implantation
MARLBOROUGH, Mass., Sept. 6, 2022 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the current-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation (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," 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."
Clinical evidence submitted to the FDA to support 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 data was submitted to the FDA to support the safety and efficacy of DAPT as a post-procedural antithrombotic regimen in patients with NVAF who may have a reason for seeking an alternative to OAC.
The labeling in Europe has included the choice of either OAC or a DAPT post-procedural drug regimen for WATCHMAN technology since 2017.
Additional Recent Clinical Data Supporting the WATCHMAN FLX Device
Recently announced real-world data for the WATCHMAN FLX device include the results of an analysis of more than 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.
Additionally, recently presented data from the SURPASS analysis of more than 16,000 patients from the NCDR-LAAO Registry demonstrated low rates of adverse events and peri-device leak through 45 days post implant, and, in the investigator-led SEAL-FLX study – the first study exclusively comparing the WATCHMAN FLX device vs. the Amplatzer™ Amulet™ device – there was a significantly higher rate of complete occlusion of the left atrial appendage at eight weeks with the WATCHMAN FLX technology compared to the Amulet device (
Ongoing studies with the WATCHMAN FLX device include the CHAMPION-AF and OPTION clinical trials to evaluate use of the device for broader patient populations with NVAF.
For more information on the WATCHMAN FLX device, visit www.watchman.com/implanter.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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FAQ
What is the significance of the FDA approval for Boston Scientific's WATCHMAN FLX device?
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What clinical data supports the use of DAPT after WATCHMAN FLX implantation?
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