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Medtronic gains FDA approval for longer DCB to treat patients with SFA disease

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Medtronic announced that the FDA has approved a longer length of its drug-coated balloon for treatment of superficial femoral artery disease.

The DCB (IN.PACT Admiral) is 150 mm long and is available in diameters of 4 mm, 5, and 6 mm, which provides more treatment options for patients with long lesions in the SFA, the company stated in a press release.

“The long lesion (10 cm to 18 cm) subgroup outcomes from the IN.PACT SFA Trial at 1 year demonstrated superiority over balloon angioplasty,” John Laird, MD, interventional cardiologist at University of California – Davis Medical Center, Sacramento, and principal investigator for the trial, said in the release. “The availability of the 150-mm length sizes will expand proven treatment options to more patients.”

John Laird

In the long-lesion subgroup of the IN.PACT SFA trial, the clinically driven target lesion revascularization rate was 5.3 % for the DCB arm (n = 79) and 32.4% for the PTA arm (n = 36; P < .001). Researchers also found a 3.9% thrombosis rate in the DCB arm vs. a 5.9% rate in the PTA arm (P = .326) in the long-lesion subgroup. There were no device- or procedure-related deaths and no instances of major target limb amputation in the subgroup.

Disclosure: Laird reports consulting and serving on advisory boards for Abbott Vascular, Bard, Boston Scientific and Medtronic, and receiving research support from Gore and Medtronic.