Boston Scientific (NYSE: BSX) has received expanded FDA approval for the use of its Watchman FLX and Watchman FLX Pro devices.
The FDA’s premarket approval (PMA) database says the left atrial appendage closure (LAAC) devices now have expanded indications to include patients following catheter ablation for non-valvular AFib and to add a new post-implant drug regimen to the device labeling.
Boston Scientific’s Cat Jennings and Kristin LaRocca will share Boston Scientific’s formula for integrating acquired MedTech companies on a panel at DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register at West.DeviceTalks.com.
Both devices already had indications to reduce the risk of thromboembolism from the LAA in patients with non-valvular AFib. They reduce stroke risk in such patients who need an alternative to oral anticoagulation therapy. The next-generation FLX devices feature a polymer coating, visualization markers and a broader size matrix. The company says this design helps to treat a wider range of patients.
Boston Scientific previously suggested that it expected a label expansion some time in the second half of 2025 based on positive results from the OPTION trial. CEO Mike Mahoney said in January that Watchman would prove to be a massive growth driver moving forward as well.
BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang say the approval comes as expected. They note that the updated label specifies the use of Watchman either concomitantly or sequentially, plus the new post-imlpant drug regimen. The analysts maintain their “Buy” rating.
“We are pleased to see BSX receive a formal label expansion to include post-ablation patients and view this as an important milestone validating the value proposition of concomitant LAAC and PFA procedures using Watchman,” the analysts wrote. “Our estimates are not under review. Reiterate Buy.”
Boston Scientific’s Cat Jennings and Kristin LaRocca will share Boston Scientific’s formula for integrating acquired MedTech companies on a panel at DeviceTalks West, Oct. 15–16, 2025 in Santa Clara, California. Register at West.DeviceTalks.com.
