FDA Approves 150-mm Lengths for Medtronic’s In.Pact Admiral DCB
July 13, 2016—Medtronic plc announced US Food and Drug Administration (FDA) approval for the In.Pact Admiral drug-coated balloon (DCB) in longer, 150-mm lengths. The new 150-mm-length balloon, available in diameters of 4, 5, and 6 mm, will provide more treatment options for long lesions of the superficial femoral artery (SFA) in patients with peripheral artery disease (PAD).
The In.Pact Admiral DCB received the European CE Mark approval in 2009 to treat PAD and was approved by the FDA December 2014 to treat the SFA and the popliteal artery.
John Laird, MD, who served as Coprincipal Investigator for the IN.PACT SFA trial commented in Medtronic’s press release, “The long lesion (10–18 cm) subgroup outcomes from the IN.PACT SFA trial at 1 year demonstrated superiority over balloon angioplasty. The availability of the 150-mm-length sizes will expand proven treatment options to more patients.” Dr. Laird is an interventional cardiologist at the University of California–Davis Medical Center in Davis, California.
In a subgroup of patients with lesions ≥ 10 cm and < 18 cm, the prospective, multicenter, randomized controlled pivotal IN.PACT SFA trial demonstrated a clinically driven target lesion revascularization rate of 5.3% for the In.Pact Admiral DCB arm (n = 79) and 32.4% for the PTA arm (n = 36) (P < .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 = .326) in this subgroup. These data do not include the 150-mm lengths of the In.Pact Admiral DCB, advised the company.