FDA Approves Drug-Coated Balloon to Help Treat Peripheral Artery Disease in Upper Leg

The FDA today approved Medtronic Inc’s IN.PACT Admiral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) in the upper leg.

This interventional treatment is intended to help treat this condition, which has been associated with a 4- to 5-fold increase in the risk of heart attack and stroke. Medtronic reported its product will help lower procedure costs for patients with PAD.

The DCB works by reopening superficial femoral and popliteal arteries that have been narrowed or blocked by plaque. The balloon then deploys a dose of the antirestenotic drug paclitaxel to the artery walls and is intended to prevent the artery from narrowing again by minimizing scar tissue formation, according to Medtronic.

"The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease in the leg," said Michael R. Jaff, Paul and Phyllis Fireman chairman in vascular medicine at the Massachusetts General Hospital, professor of medicine at Harvard Medical School, and a participator in the study, in a press release.

A study of the product showed the lowest clinically driven target lesion revascularization rate ever reported for an interventional treatment of PAD in the superficial femoral artery, Medtronic stated. While 1 in 5 patients treated with percutaneous transluminal angioplasty needed a repeat procedure at 1 year, only 2.4% of patients treated with IN.PACT Admiral DCB needed a repeat procedure.