Cagent Vascular announced that it received FDA 510(k) clearance for its Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter.
The FDA indication is for use of the Serranator for treating below-the-knee (BTK) lesions, making it the first and only angioplasty balloon with FDA clearance and CE Mark approval that embeds serration technology into a semi-compliant balloon for treating peripheral artery disease (PAD), according to a news release.
The catheter, designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion, is being used in the Prelude-BTK study. The prospective, single-arm, multi-center feasibility study to showcase safety and efficacy enrolled 49 patients across six centers and will observe 30-day and six-month follow-ups.
“This trial enrolled quickly, which speaks to the enthusiasm for better technology like the Serranator,” principal investigator Dr. Andrew Holden (Auckland, New Zealand) said in the release. “Treating BTK lesions is a challenge due to the unpredictability we often see with existing balloon therapy such as insufficient lumen gain, vessel dissection and recoil. These arteries are small in diameter, often calcified, with much of the disease located in the distal portion of the leg, making treatment a challenge.”
The Serranator is offered for the infrapopliteal indication at 2.5, 3.0 and 3.5mm balloon diameters and 40, 80 and 120mm balloon lengths. Cagent Vascular said it now plans to complete the manufacturing validations for the product and expand its clinical use with U.S. physicians.
“Obtaining FDA clearance and completion of the Prelude-BTK trial enrollment were critical milestones for the company’s growth,” Cagent Vascular president & CEO Carol Burns said. “We are grateful to our investigators for treating these subjects and are encouraged by the positive acute angiographic results.
“We believe serration technology is truly differentiating in its ability to achieve lumen expansion and restore blood flow with minimal injury. Our goal is for the Serranator to become the standard of care for balloon-based peripheral interventions.”