June 14, 2018
FDA Approves Extended Balloon Lengths for Medtronic's In.Pact Admiral DCB
June 15, 2018—Medtronic announced that it has received US Food and Drug Administration (FDA) approval for 200- and 250-mm lengths of its In.Pact Admiral drug-coated balloon to treat long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
In the company's announcement, Gary Ansel, MD, commented, "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. The approval of the In.Pact Admiral 200- and 250-mm 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.” Dr. Ansel is System Medical Director for Vascular Services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio.
Medtronic noted that in April, the paclitaxel-coated In.Pact Admiral received FDA approval to treat SFA lesions up to 360 mm 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 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. Findings included 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.Pact Admiral received European CE Mark approval in March 2009 to treat PAD and was approved by the FDA in December 2014 to treat and popliteal arteries, advised Medtronic.