Medtronic Gets FDA Nod on Drug-Coated Balloon for PAD In-Stent Restenosis

Larry Hand


September 14, 2016

DUBLIN, IRELAND — The US Food and Drug Administration has approved Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) as the first DCB to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD), the company announced[1].

The approval is based on data from the IN.PACT Global Study, which demonstrated the DCB’s safe and effective treatment of complex ISR when compared with a standard percutaneous transluminal angioplasty (PTA) control.

The study showed a 1-year primary patency rate of 88.7% for a difficult-to-treat ISR patient subgroup, with a clinically driven target revascularization rate of 7.3%. Lesions had a mean length of 17.2 cm, and 34% of lesions were occluded.

Medtronic officials said the IN.PACT study was designed "to look at challenging lesions in real-world patients.'

The primary mode of action for the DCB is physical dilation of the vessel lumen by PTA. Physicians can use it to treat claudication and restenosis in patients with superficial femoral artery disease.

The balloon is coated with paclitaxel, which is used to minimize scar tissue formation and prevent artery narrowing.

The IN.PACT Admiral DCB, which received the CE Mark in 2009 and was approved by the FDA to treat superficial femoral and popliteal arteries in 2014, has been used to treat more than 150,000 patients, according to Medtronic.

The Bard Lutonix paclitaxel-coated DCB received FDA approval in 2014 for treatment of initial stenosis but not for restenosis.

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