Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon catheter


Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator is the first of a family of peripheral artery disease technologies under development which incorporate proprietary Serration technology to an angioplasty balloon.

“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries. Today we are treating more complex lesions that require better tools. The Serranator is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion,” says vascular surgeon Peter Schneider (Hawaii, USA).

“We believe Serration technology will prove to be effective in more complex lesions and will evolve into the new standard of care for vessel dilatation. In the future we hope to show clinical benefit as a vessel preparation tool with new technologies such as drug coated balloons,” continued Schneider.

Cagent Vascular has received FDA clearance for its first product, Serranator Alto, indicated for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

“FDA clearance represents a significant milestone. Our next step is to initiate a study to assess the clinical safety and efficacy of the technology,” says chief executive officer Carol Burns. “We have also begun the development of the Serranator Bass for treatment of the below-the-knee or infrapopliteal arteries, where new technologies are desperately needed for the treatment of critical limb ischaemia. Future applications of interest include Serration technology for vessel preparation prior to the use of bioresorbable scaffolds in coronary arteries.”