Medtronic receives FDA approval for IN.PACT Admiral DCB 150mm lengths

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IN.PACT Admiral DCB

Medtronic has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150mm lengths. The 150mm length balloon, available in 4mm, 5mm, and 6mm diameters, will provide greater treatment options for long lesions in patients with peripheral arterial disease.

“The long lesion (10–18 cm) 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 (CD-TLR) rate of 5.3% for the IN.PACT Admiral DCB arm (n=79) and 32.4% for the percutaneous  transluminal angioplasty (PTA) 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 DCB arm versus 5.9% in the PTA arm through 12 months (p=0.326) in this subgroup.