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Medtronic Gets FDA Approval For IN.PACT Admiral DCB 150 mm Lengths


Medtronic plc (NYSE: MDT) disclosed that it received FDA approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150 mm lengths. According to the company, the new 150 mm length balloon is available in four, five, and six mm diameters. It would offer greater treatment options for long lesions in patients with peripheral artery disease (PAD).

Medtronic said the IN.PACT SFA Trial, a prospective, multi-center, randomized, controlled pivotal study demonstrated, in a subgroup of patients with lesions >=10 cm and <18 cm, a clinically-driven target lesion revascularization (CD-TLR) rate of 5.3 percent for the IN.PACT Admiral DCB arm (n=79) and 32.4 percent for the PTA arm (n=36) (p<0.001). The company indicated that there were no device or procedure-related deaths, no occurrences of big target limb amputation, and a 3.9 percent thrombosis rate in the IN.PACT Admiral DCB arm compared to 5.9 percent in the PTA arm through 12 months (p=0.326) in this subgroup.

The company's VP and GM of the Peripheral business, Mark Pacyna, said, "The expansion of IN.PACT Admiral DCB to 150 mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment. The IN.PACT Admiral platform continues to show durable, consistent, and safe outcomes."

Interventional Cardiologist at U.C. Davis Medical Center and co-principal investigator, John Laird, said, "The long lesion (10-18 cm) sub-group outcomes from the IN.PACT SFA Trial at one year demonstrated superiority over balloon angioplasty. The availability of the 150 mm length sizes will expand proven treatment options to more patients."

Posted-In: Biotech News FDA General


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