The US Food and Drug Administration (FDA) has approved Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) for the treatment of long superficial femoral artery (SFA) lesions.
The indication allows the use of the DCB for up to 360mm SFA lesions in peripheral artery disease (PAD) patients.
IN.PACT Admiral is designed as a primary endovascular therapy for treating claudication and restenosis in patients with SFA disease.
The DCB works by dilating the vessel lumen, while the coated paclitaxel drug is set to reduce the formation of scar tissue to prevent artery narrowing.
Medtronic Peripheral business vice-president and general manager Mark Pacyna said: “With this approval, IN.PACT Admiral is now indicated to treat the longest lesions of any commercially-available DCB or peripheral stent in the US, providing physicians with additional confidence in using this DCB as part of their treatment algorithm.
“In partnership with the clinical community, we look forward to continued collaboration as we work to address additional treatment challenges in PAD with this device.”
The FDA approval follows the review of findings from a total of 227 subjects across the complex lesion imaging cohorts in the IN.PACT Global Study.
Study evaluation included long lesion, in-stent restenosis and chronic total occlusion (CTO) groups whose lesions were greater than 180mm.
Results demonstrated 89.1% one-year patency rate at day 360 and 7.1% clinically-driven target revascularisation (CD-TLR) rate.
The IN.PACT Admiral DCB secured the European CE-Mark in 2009 for PAD treatment and the US FDA approval in 2014 for superficial femoral and popliteal arteries.