Cagent Vascular said today that it won 510(k) clearance from the FDA for its Serranator Alto balloon catheter, which is designed to treat peripheral artery disease.
The Wayne, Pa.-based company bills its serration technology, created by co-founder and CMO Dr. Peter Schneider, as a way to improve arterial expansion during balloon angioplasty for PAD. The device’s balloon has serrated external metal strips designed to create linear “micro-serrations,” according to Cagent’s website.
“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,” Schneider, a vascular surgeon, said in prepared remarks. “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.”
The FDA indications includes 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, Cagent said.
“FDA clearance represents a significant milestone. Our next step is to initiate a study to assess the clinical safety and efficacy of the technology,” CEO Carol Burns said. “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 Ischemia. Future applications of interest include Serration Technology for vessel preparation prior to the use of Bioresorbable Scaffolds in coronary arteries.”