FDA News

FDA approves DCB in larger sizes for treatment of long lesions in PAD

Gary M. Ansel
Gary Ansel

Medtronic announced the FDA approved longer lengths of its drug-coated balloon designed for the treatment of long superficial femoral artery lesions in patients with peripheral artery disease.

According to a press release from Medtronic, complex lesions, including those over 150 mm, remain a significant treatment challenge for physicians.

The approval of the 200-mm and 250-mm versions of the DCB (IN.PACT Admiral) comes after the FDA in April granted a new indication for the DCB to treat lesions as long as 360 mm, according to the release.

The new 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 > 180mm. These groups consisted of 227 patients with mean lesion lengths of 28.7 ± 7.1 cm. The analysis of these patients showed 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%, according to the release.

"As [superficial femoral artery] 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," Gary Ansel, MD, system medical director for vascular services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio, and a Cardiology Today’s Intervention Editorial Board Member, said in the release. "The approval of the IN.PACT Admiral 200 mm 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."

Disclosures: Ansel reports he receives honoraria from Bard Peripheral Vascular, Cook Medical, Cordis and Medtronic; and consults for 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Best Doctors, Boston Scientific, Cardinal Health, Cook Medical, Cordis, Ostial, Reflow Medical, Philips, Shockwave Medical, Surmodics, Veryan/Novate and W.L. Gore and Associates.

Gary M. Ansel
Gary Ansel

Medtronic announced the FDA approved longer lengths of its drug-coated balloon designed for the treatment of long superficial femoral artery lesions in patients with peripheral artery disease.

According to a press release from Medtronic, complex lesions, including those over 150 mm, remain a significant treatment challenge for physicians.

The approval of the 200-mm and 250-mm versions of the DCB (IN.PACT Admiral) comes after the FDA in April granted a new indication for the DCB to treat lesions as long as 360 mm, according to the release.

The new 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 > 180mm. These groups consisted of 227 patients with mean lesion lengths of 28.7 ± 7.1 cm. The analysis of these patients showed 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%, according to the release.

"As [superficial femoral artery] 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," Gary Ansel, MD, system medical director for vascular services at OhioHealth Riverside Methodist Hospital in Columbus, Ohio, and a Cardiology Today’s Intervention Editorial Board Member, said in the release. "The approval of the IN.PACT Admiral 200 mm 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."

Disclosures: Ansel reports he receives honoraria from Bard Peripheral Vascular, Cook Medical, Cordis and Medtronic; and consults for 480 Biomedical, Abbott Vascular, Bard Peripheral Vascular, Best Doctors, Boston Scientific, Cardinal Health, Cook Medical, Cordis, Ostial, Reflow Medical, Philips, Shockwave Medical, Surmodics, Veryan/Novate and W.L. Gore and Associates.