Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360mm in patients with peripheral artery disease (PAD).
Approval 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 (CTO) groups with lesion lengths >180mm. Across these groups, a total of 227 subjects with mean lesion lengths of 28.7±7.1cm were analysed. Data showed a one-year patency rate of 89.1% by Kaplan Meier estimate at day 360, and a clinically-driven target revascularisation (CD-TLR) rate of 7.1%.
“Data from the IN.PACT Global Study demonstrate that the DCB is a safe and effective treatment option in real-world patients with lesions beyond 180mm, frequently comprised of in-stent restenosis and chronic total occlusions,” said Daniel Clair, chair of the Department of Surgery for University of South Carolina (USC) and the Palmetto Health-USC Medical Group. “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 US physicians a clinically-proven endovascular therapy to address this critical patient need.”
Complex lesions, including those over 150mm, remain a significant treatment challenge for physicians.
“In conversations with physicians, a key clinical challenge raised is the ability to provide a sustainable treatment option for longer length, complex lesions. With this approval, IN.PACT Admiral is now indicated to treat the longest lesions of any commercially-available DCB or peripheral stent in the US, providing physicians with additional confidence in using this DCB as part of their treatment algorithm,” said Mark Pacyna, vice president and general manager of the Peripheral business, which is part of the Aortic & Peripheral Vascular division at Medtronic. “In partnership with the clinical community, we look forward to continued collaboration as we work to address additional treatment challenges in PAD with this device.”