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.

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.