FDA Clears IN.PACT Admiral DCB, Low-Profile PTA Balloon Catheter for PAD

The US Food and Drug Administration (FDA) has approved the IN.PACT Admiral Drug-Coated Balloon (DCB) for the treatment of long superficial femoral artery (SFA) lesions that are up to 360 mm in patients with peripheral artery disease (PAD).

The Medtronic device was approved 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. Mean lesion lengths were 28.7±7.1 cm.

"Data from the IN.PACT Global Study demonstrate that IN.PACT Admiral DCB is a safe and effective treatment option in real-world patients with lesions beyond 180 mm, frequently comprised of in-stent restenosis and chronic total occlusions," said Daniel Clair, MD, the chair of the Department of Surgery for University of South Carolina and the Palmetto Health-USC Medical Group, in a statement. "More specifically, these results show maintenance of strong clinical outcomes, including a high primary patency rate and limited need for reintervention in patients exhibiting these complex, long lesions - among the most prevalent cases we see. The FDA's approval of this expanded indication now offers U.S. physicians a clinically-proven endovascular therapy to address this critical patient need."

Data revealed a patency rate of 89.1% at year 1, measured by a Kaplan Meier estimate, and freedom from clinically-driven target revascularization (CD-TLR) rate of 92.6%. In the Global Clinical cohort, 1207 of 1311 patients (92.1%) reached the primary safety composite, consisting of freedom from device- and procedure-related death to 30 days, freedom from target limb amputation within 12 months; and freedom from clinically-driven target vessel revascularization within 1 year.

"In conversations with physicians, a key clinical challenge raised is the ability to provide a sustainable treatment option for longer length, complex lesions. With this approval, IN.PACT Admiral is now indicated to treat the longest lesions of any commercially-available DCB or peripheral stent in the U.S., providing physicians with additional confidence in using this DCB as part of their treatment algorithm," Mark Pacyna, the vice president and general manager of the Peripheral business, part of the Aortic & Peripheral Vascular division at Medtronic, said in a statement. "In partnership with the clinical community, we look forward to continued collaboration as we work to address additional treatment challenges in PAD with this device."

On a similar note, the FDA also approved Surmodics, Inc.’s .018” Low-Profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, with an indication for a broad range of peripheral vascular applications for patients with PAD. The balloon has an offering range of 2 mm to 10 mm.

Surmodics reportedly expects to make the product available for distribution in the coming months of 2018.

“We are delighted to announce this latest of three recent FDA clearances, adding further depth to our proprietary product offerings. With the .018” Low-Profile PTA balloon catheter, we continue building upon Surmodics’ portfolio of differentiated products that are designed to advance the treatment of vascular disease,” said Gary Maharaj, the president and CEO of Surmodics, in a statement. “This regulatory milestone adds to the recent clearances of the Telemark .014” Support Microcatheter and the .014” BTK Balloon Dilatation Catheter.”

As more than 200 million patients have PAD worldwide, including 12-20% of Americans older than 60, these devices provide additional treatment options for an often-underdiagnosed condition.