Cagent Vascular's Serranator Alto Balloon Catheter Receives FDA Clearance
February 27, 2017—Cagent Vascular announced US Food and Drug Administration 510(k) clearance of the company's first product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter for the treatment of peripheral artery disease. The Serranator Alto is 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.
“A new approach to vessel dilatation is long overdue for treatment of diseased peripheral arteries," commented vascular surgeon Peter Schneider, MD, who serves as Chief Medical Officer for Cagent Vascular, in the company's announcement. "Today, we are treating more complex lesions that require better tools. The Serranator is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion.”
Dr. Schneider continued, “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 company advised that it will be initiating a study to assess the clinical safety and efficacy of the technology. In addition, Cagent Vascular has begun development of the Serranator Bass for the treatment of critical limb ischemia in the below-the-knee or infrapopliteal arteries.