The 200 and 250 millimeter lengths of Medtronic’s IN.PACT Admiral drug-coated balloon gained FDA approval to treat long superficial artery (SFA) lesions in patients with peripheral artery disease (PAD), the company announced June 15.
The approval was based on data from the IN.PACT Global Study, which showed a one-year patency rate of 89.1 percent and a clinically driven target revascularizations rate of 7.1 percent among participants with lesions longer than 180 mm. Patients included those with long lesions, in-stent restenosis and chronic total occlusions.
"As SFA disease progresses, we tend to see patients present with longer, more complex lesions,” Gary Ansel, MD, system medical director for vascular services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio, said in a press release. “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 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."
More than 200,000 patients have been treated with paclitaxel-coated IN.PACT Admiral balloons, according to Medtronic. They first received CE mark approval in 2009 to treat PAD and were awarded FDA approval in 2014 to treat superficial femoral and popliteal arteries.