Data revealed that the 1-year patency rate was 89.1% via Kaplan Meier estimate at day 360, and a CD-TLR rate of 7.1%.
The US Food and Drug Administration (FDA) has approved the use of Medtronic’s IN.PACT Admiral Drug-Coated Balloon (DCB) 200 mm and 250 mm lengths, for the treatment of long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD).
This approval comes shortly after the Dublin-based company’s IN.PACT DCB was greenlit in April for the 360 mm length for SFA lesions, which made it the first DCB granted this indication. As these lesions are commonly encountered—including those over 150 mm—the new indication will allow for the more widespread use of the DCB.
"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, MD, the system medical director for Vascular Services at OhioHealth Riverside Methodist Hospital in Columbus, in a statement. "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."
The FDA’s decision was made based on data from the phase 3 IN.PACT Global Study, which included 1416 patients that had either long lesion (n = 157), in-stent restenosis (n = 131), and chronic total occlusion (CTO; n = 126) groups with lesion lengths >180 mm.
Across those groups, the mean lesion lengths were 28.7±7.1 cm, and a total of 227 subjects were analyzed. The data revealed that the 1-year patency rate was 89.1% via Kaplan Meier estimate at day 360, and a clinically-driven target revascularization (CD-TLR) rate of 7.1%.
"In our IN.PACT Global Study, IN.PACT Admiral demonstrated safety and effectiveness in real-world patients with complex lesions, including long lesions," Mark Pacyna, the vice president and general manager of the Peripheral business in Medtronic's Cardiac & Vascular Group, said in a statement. "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."
The DCB was originally approved in Europe in March 2009 and gained its first FDA go-ahead in December 2014. Thus far, more than 200,000 patients have been treated with the device, according to Medtronic.