FDA approves IN.PACT Admiral Drug-Coated Balloon for superficial femoral artery lesions in PAD.- Medtronic.

Medtronic announced that it has received FDA approval for the IN.PACT Admiral Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD). Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion (CTO) groups with lesion lengths more than 180mm. Across these groups, a total of 227 subjects with mean lesion lengths of 28.7 plus or minus 7.1 cm were analyzed. Data showed a one-year patency rate of 89.1 percent by Kaplan Meier estimate at day 360, and a clinically-driven target revascularization (CD-TLR) rate of 7.1 percent.

Comment: IN.PACT Admiral received the CE Mark in March 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. It has been studied in more than 20 individual clinical trials demonstrating durable safety and clinical benefits. To date, more than 200,000 patients have been treated with IN.PACT Admiral. It is the only DCB to have published three-year data and the first to have presented four-year data from a pivotal randomized trial.