An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee.
The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The panel also voted 14-to-3 against whether the benefits outweigh the risks. There was one abstained vote for each measure.
The Lutonix 014 Drug-Coated Balloon PTA catheter had a proposed indication for use for percutaneous transluminal angioplasties of obstructive de novo or non-stented restenotic lesions in popliteal, tibial and perineal arteries up to 320 mm in length.
Original Article: (https://www.massdevice.com/fda-panel-votes-against-bd-lutonix-drug-coated-balloon-for-below-the-knee/)