Medtronic gets FDA nod for longer, 150mm length, IN.PACT Admiral drug-coated balloon

In.pact Admiral

Medtronic has received US FDA approval for the IN.PACT Admiral drug-coated balloon in longer, 150mm, lengths. The new 150mm length balloon, available in four, five, and six millimetre diameters, will provide greater treatment options for long lesions in patients with peripheral artery disease.

“The long lesion (10–18cm) subgroup outcomes from the IN.PACT SFA trial at one year demonstrated superiority over balloon angioplasty,” said John Laird, interventional cardiologist at UC Davis Medical Center and co-principal investigator for the IN.PACT SFA trial. “The availability of the 150mm length sizes will expand proven treatment options to more patients.”

The IN.PACT SFA trial, a prospective, multicentre, randomised, controlled pivotal trial demonstrated, in a subgroup of patients with lesions ≥10cm and <18cm, a clinically-driven target lesion revascularisation rate of 5.3% for the In.pact Admiral arm (n=79) and 32.4% for the percutaneous transluminal angioplasty alone arm (n=36) (p<0.001).

There were no device or procedure-related deaths, no occurrences of major target limb amputation, and a 3.9% thrombosis rate in the IN.PACT Admiral arm vs. 5.9% in the percutaneous transluminal angioplasty alone arm through 12 months (p=0.326) in this subgroup.

“The expansion of IN.PACT Admiral drug-coated balloon to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” said Mark Pacyna, vice president and general manager of the peripheral business, which is part of the Aortic and Peripheral Vascular division at Medtronic. “The IN.PACT Admiral platform continues to show durable, consistent, and safe outcomes.”

The IN.PACT Admiral drug-coated balloon is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery disease. The drug-coated balloon’s primary mode of action is physical dilatation of the vessel lumen by percutaneous transluminal angioplasty, and the proven paclitaxel drug is intended to prevent artery narrowing by minimising scar tissue formation.