The FDA approved Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease, the medtech giant touted today.
In a 227-patient global trial, participants treated with Medtronic’s drug-device combination therapy had a one-year patency rate of 89.1% and a clinically-driven target revascularization rate of 7.1%.
“Data from the In.Pact Global Study demonstrate that In.Pact Admiral DCB is a safe and effective treatment option in real-world patients with lesions beyond 180 mm, frequently comprised of in-stent restenosis and chronic total occlusions,” Dr. Daniel Clair, chair of the dept. of surgery for University of South Carolina, said in prepared remarks.
“In conversations with physicians, a key clinical challenge raised is the ability to provide a sustainable treatment option for longer length, complex lesions. With this approval, In.Pact Admiral is now indicated to treat the longest lesions of any commercially-available DCB or peripheral stent in the U.S., providing physicians with additional confidence in using this DCB as part of their treatment algorithm,” Mark Pacyna, VP& GM of Medtronic’s peripheral business, added.
The FDA first approved the In.Pact Admiral balloon to treat superficial femoral and popliteal arteries in December of 2014. It was the first drug-coated balloon to win approval by the FDA for the treatment of in-stent restenosis, according to Medtronic.