Medical device manufacturer Boston Scientific Corp., based in Marlborough, has received authorization to expand instructions for use labeling for its WATCHMAN FLX Left Atrial Appendage Closure device, the company announced on Tuesday, providing an additional option for doctors to approach blood clot prevention after the device is installed.
The expansion includes an option for a 45-day dual antiplatelet therapy (DAPT) as an alternative to a 45-day oral anticoagulation and aspirin (OAC) post-procedural treatment for patients with non-valvular atrial fibrillation, according to the announcement.
“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 at Boston Scientific, in a statement.
While the FDA approval is new, European labeling has included both OAC or DAPT post-procedural drug regiments since 2017, according to Boston Scientific.
