The US Food and Drug Administration (FDA) has approved Medtronic‘s In.Pact Admiral drug-coated balloon for the treatment of long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease.
The approval was based on clinical results from the complex lesion imaging cohorts of the In.Pact global study, which comprised of long lesion, in-stent restenosis, and chronic total occlusion (CTO) groups with lesion lengths greater than 180mm.
The In.Pact Admiral DCB is a primary endovascular therapy, which allows physicians to treat claudication and restenosis in patients with SFA disease.
Medtronic analyzed 227 subjects with mean lesion lengths of 28.7 ± 7.1cm across these groups.
The company said the data demonstrated a one-year patency rate of 89.1% by Kaplan Meier estimate at day 360, and a clinically-driven target revascularization (CD-TLR) rate of 7.1%.
Medtronic aortic and peripheral vascular division’s peripheral business general manager and vice president Mark Pacyna said: "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.”
PAD is a serious and chronic condition, which affects over 200 million across the globe, and arteries in the legs become narrowed or blocked by plaque in these condition.
The primary mode of action of In.Pact Admiral DCB is physical dilatation of the vessel lumen by PTA, while paclitaxel drug will prevent artery narrowing by minimizing scar tissue formation.
In 2009, the In.Pact Admiral secured CE mark approval to treat PAD. In December 2014, the DCB secured FDA approval to treat superficial femoral and popliteal arteries.
Image: Medtronic operational headquarters. Photo: courtesy of Medtronic.