FDA Approves Expanded Indication for Medtronic's In.Pact Admiral DCB to Treat Long SFA Lesions
April 23, 2018—Medtronic announced that it has received US Food and Drug Administration (FDA) approval for its In.Pact Admiral drug-coated balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360 mm in patients with peripheral artery disease.
According to Medtronic, approval for the expanded indication was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global study, including long lesion in-stent restenosis and chronic total occlusion groups with lesion lengths > 180 mm. Across these groups, investigators analyzed a total of 227 patients with mean lesion lengths of 28.7 ± 7.1 cm. Data showed a 1-year patency rate of 89.1% by Kaplan Meier estimate at day 360, and a clinically driven target revascularization rate of 7.1%.
In December 2014, the In.Pact Admiral device was approved by the FDA to treat superficial femoral and popliteal arteries. The device received the European CE Mark approval in March 2009.
In the company's press release, Daniel Clair, MD, commented, “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. 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 United States physicians a clinically proven endovascular therapy to address this critical patient need.” Dr. Clair is Chair of the Department of Surgery for University of South Carolina (USC) and the Palmetto Health-USC Medical Group in Columbia, South Carolina.