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 ± 7.1 cm were analyzed. Data showed a one-year patency rate of 89.1 percent by Kaplan Meier estimate at day 360, and a clinically-driven target revascularization (CD-TLR) 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," said Daniel Clair, M.D., 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 U.S. physicians a clinically-proven endovascular therapy to address this critical patient need."
PAD is a serious, chronic condition that affects more than 200 million people worldwide.1 In PAD, arteries in the legs become narrowed or blocked by plaque. This narrowing of the blood vessel reduces blood flow to the leg, which can result in severe pain and limit physical mobility.2 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 U.S., 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."
1Fowkes, F. G., et al. (2013). Lancet 382(9901): 1329-1340.
2Roberts, D., et al. (2014). Catheter Cardiovasc Interv 84(2): 236-244.