Advertisement
Advertisement
February 17, 2021
FDA Panel Votes Against Recommending PMA for BD’s Lutonix 014 DCB for CLI
February 17, 2021—The Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee met to discuss and make recommendations on the premarket approval application (PMA) for BD’s Lutonix 014 drug-coated balloon (DCB), including whether the device demonstrates a reasonable assurance of safety and effectiveness in treating patients with critical limb ischemia (CLI).
The panel’s meeting materials are available online here.
BD, the PMA’s sponsor, proposed the following Indications for Use: “The Lutonix 014 DCB PTA catheter is indicated for patients with critical limb ischemia who have obstructive de novo or nonstented restenotic lesions in native popliteal, tibial, and peroneal arteries up to 320 mm in length and 2 to 4 mm in diameter.”
The FDA reported that the panel voted in favor of the device’s safety (15-2; one abstention) but not in favor of its effectiveness (2-15; one abstention) nor that its benefits outweigh the risks (3-14; one abstention) for the proposed indication.
The FDA summary of the panel deliberations is available here.
The Lutonix 014 DCB has been commercially available in Europe, Canada, and Australia for the treatment of the below-the-knee arteries in patients with CLI since 2013.
Advertisement
Advertisement
