- Boston Scientific ( NYSE: BSX ) said it received U.S. Food and Drug Administration (FDA) approval the expanded labeling for for the current-generation Watchman FLX Left Atrial Appendage Closure (LAAC) Device.
- The new labeling instruction allows, to include a 45-day dual anti-platelet therapy (DAPT) option as an alternative to 45-day oral anticoagulation plus aspirin for post-procedural treatment of patients with non-valvular atrial fibrillation (NVAF), the company said in a Sept. 6 press release.
- "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 Ian Meredith, global chief medical officer, Boston Scientific.
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Boston Scientific gets FDA nod for label expansion for Watchman device use with dual anti-platelet therapy