January 5th, 2015
FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries
Medtronic said today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication.
The new DCB uses the anti-proliferative drug paclitaxel, which is designed to prevent renarrowing (restenosis) of the blood vessel after it is opened by the expanded balloon. Approval of the device was based on the landmark IN.PACT SFA trial published last month in Circulation. Target lesion revascularization was dramatically reduced in that trial from 20.6% in the group who received standard balloon angioplasty to 2.4% in the DCB group. Medtronic noted in its statement that approval had been granted without the use of an FDA advisory panel.
The IN.PACT Admiral DCB has been available in Europe since 2009.