The FDA approved Medtronic’s IN.PACT Admiral drug-coated balloon for treating in-stent restenosis in patients with peripheral artery disease.

The expanded indication for the device marks the first approval in the U.S. for a drug-coated balloon (DCB) to treat in-stent restenosis. The agency approved the device in 2014 to treat superficial femoral and popliteal arteries.

In-stent restenosis occurs when a stent is placed in the artery to restore blood flow, but over time plaque can form in and around the stent. This condition is estimated to occur in up to 40 percent of all stents placed in the superficial femoral artery, according to Medtronic. — Tamra Sami