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Peripheral DCB now approved for treatment of long lesions

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Medtronic announced the FDA approved its drug-coated balloon for treatment of patients with long superficial femoral artery lesions up to 360 mm.

According to a press release from the company, the approval of the new indication for the DCB (IN.PACT Admiral) was based on the results of the IN.PACT Global study, which found that in a subset of 227 patients with mean lesion length of 28.7 cm, 1-year patency was 89.1% and 1-year clinically driven target lesion revascularization was 7.1%.

“Data from the IN.PACT Global Study demonstrate that IN.PACT Admiral DCB is a safe and effective treatment option in real-world patients with lesions beyond 180 mm, frequently comprised of in-stent restenosis and chronic total occlusions,” Daniel Clair, MD, chair of the department of surgery for university of South Carolina and the Palmetto Health-USC Medical Group, said in a press release. “These results show maintenance of strong clinical outcomes, including a high primary patency rate and limited need for reintervention in patients exhibiting these complex, long lesions — among the most prevalent cases we see. The FDA’s approval of this expanded indication now offers U.S. physicians a clinically proven endovascular therapy to address this critical patient need.”

The device was initially approved in January 2015 for treatment of peripheral artery disease in the upper leg. In September 2016, the device received approval for treatment of patients with PAD and in-stent restenosis.

Disclosures: Clair reports he serves on the data and safety monitoring board for C.R. Bard and on advisory boards for Boston Scientific and Medtronic, and consults for Endologix. The IN.PACT Global study was funded by Medtronic.