Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons

Saturday, June 16, 2018

Medtronic plc today announced that it has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).

"As SFA disease progresses, we tend to see patients present with longer, more complex lesions. As a result, these lesions become incredibly challenging to treat and often require interventions with multiple technologies to effectively treat the entire segment," said Gary Ansel, M.D., system medical director for Vascular Services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio. "The approval of the IN.PACT Admiral 200mm and 250mm balloons provides physicians with a solution to treat these long, complex lesions with fewer devices, potentially leading to shorter procedure times and reduced procedural cost."

Complex lesions, including those over 150mm, are commonly encountered in clinical practice and remain a significant treatment challenge for physicians. In April of this year, IN.PACT Admiral received approval to treat SFA lesions up to 360mm in length. 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.

"In our IN.PACT Global Study, IN.PACT Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions," said Mark Pacyna, vice president and general manager of the Peripheral business in Medtronic's Cardiac & Vascular Group. "Our new long lesion indication - coupled with the approval of the 200mm and 250mm balloons -furthers our commitment to the clinical community by equipping them with the tools and evidence needed to effectively treat complex cases."