Cagent Vascular, a company based in Wayne, Pennsylvania, won FDA clearance for its Serranator Alto PTA Serration Balloon Catheter. Unlike other balloon catheters designed to dilate blood vessels, the Serranator Alto PTA has a series of teeth-like ridges on four sides of the balloon. As the balloon is pumped to push open a constricted vessel, the ridges create tiny serrations that help the vessel to expand. The newly formed serration lines help guide the expansion of the arteries being worked on.
The device is indicated for treating the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae, according to Cagent.
“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,” said vascular surgeon and Cagent Vascular co-founder Peter Schneider, MD, in a statement.
“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 Dr. Schneider.
Product page: Serranator…
Via: Cagent Vascular