The FDA gave Medtronic a green light to market the IN.PACT Admiral drug-coated balloon in the U.S. for cases of in-stent restenosis in patients with peripheral artery disease.
The Admiral paclitaxel-coated balloon first got FDA approval in 2014 for the treatment of superficial femoral and popliteal arteries. Now it is the only drug-coated balloon approved for in-stent restenosis, a condition common after stenting the superficial femoral artery.
“Until now physicians have had limited treatment options to address patients with in-stent restenosis,” said John R. Laird, MD, of University of California Davis Medical Center in a statement. “The FDA’s approval of IN.PACT Admiral drug-coated balloon allows us to treat patients with a durable, proven, and safe technology.”
“We are experiencing a paradigm shift in treating patients with complex PAD,” he said.
Laird was a co-principal investigator of the IN.PACT SFA Trial and presented its results last year at the annual Transcatheter Cardiovascular Therapeutics meeting. That study gave the Admiral an edge over percutaneous transluminal angioplasty when it came to freedom from clinically-driven revascularization or restenosis of the target vessel (78.9% versus 50.1%, P<0001).
Of note, there were no late “catch-up” phenomena at 1 year or beyond.