Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) has received an expanded indication from the FDA and is now cleared to treat long superficial femoral artery lesions up to 360 millimeters, the company announced April 23.
The approval comes on the heels of the IN.PACT Global study, which evaluated the DCB’s performance in 227 patients with peripheral artery disease and average lesion lengths of 28.7 centimeters. A Kaplan-Meier estimate showed a one-year patency rate of 89.1 percent and a clinically driven target revascularization rate of 7.1 percent.
"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 (USC) and the Palmetto Health-USC Medical Group, said in a press release.
"More specifically, 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."
According to the press release, the IN.PACT Admiral is now indicated to treat the longest lesions of any DCB or peripheral stent on the U.S. market.
Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.