FDA Approves Medtronic Drug-Coated Balloon for Blocked Leg Arteries
Medtronic said Monday that the FDA has approved its In.Pact Admiral drug-coated balloon to treat peripheral artery disease in the upper leg.
The approval — which was granted without FDA advisory panel review — was based on a pivotal trial that demonstrated the lowest revascularization rate ever reported for a peripheral artery disease treatment in the superficial femoral artery. Only 2.4 percent of patients required a repeat procedure after one year, compared with 20.6 percent of patients who received percutaneous transluminal angioplasty, the standard care.
In.Pact Admiral is inserted into superficial femoral and popliteal arteries that have been narrowed or blocked by plaque and opens, expanding the blood vessel. At the same time, an anti-restenotic drug, paclitaxel, is delivered to the artery walls, minimizing scarring which could cause the artery to narrow again, according to Medtronic.
The device is the second drug-coated balloon to gain FDA approval for this indication, following an October nod for CR Bard’s Lutonix.
Wells Fargo senior analyst Larry Biegelsen predicts In.Pact Admiral will grab up to 75 percent of the U.S. DCB market in 2015. “We think the uptake of DCBs will be relatively rapid in the U.S. and [Medtronic’s] superior clinical data over … Lutonix will help MDT take the lion’s share of the market,” he says.
In.Pact Admiral has been available in Europe since 2009. — Kellen Owings