April 23, 2020
FDA Clears Cagent Vascular’s Serranator Device for the Infrapopliteal Indication
April 23, 2020—Cagent Vascular announced FDA 510(k) clearance of its Serranator percutaneous transluminal angioplasty serration balloon catheter for treating below-the-knee (BTK) lesions. The Serranator device embeds serration technology into a semicompliant balloon for treating peripheral artery disease and is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion.
According to the company, the Serranator device for the infrapopliteal indication includes 2.5-, 3-, and 3.5-mm balloon diameters and 40-, 80-, and 120-mm balloon lengths. In the coming months, the company plans to complete manufacturing validations and expand its clinical experience with United States physicians.
Cagent Vascular also recently completed enrollment of its PRELUDE-BTK study. The prospective, single-arm, multicenter feasibility study is evaluating the safety and efficacy of the device and will include 30-day and 6-month follow up. A total of 49 patients were enrolled at six centers from Europe and New Zealand. The study is led by Principal Investigators Andrew Holden, MBChB, from Auckland, New Zealand, and Michael Lichtenberg, MD, from Arnsberg, Germany.
In the company’s press release, Dr. Holden commented, “This trial enrolled quickly, which speaks to the enthusiasm for better technology like the Serranator. 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.”
Investigator Marianne Brodmann, MD, from Graz, Austria, added, “Our experience with the Serranator in the PRELUDE-BTK study has been positive. In a standard BTK procedure using plain old balloon angioplasty, we often see impaired flow due to recoil. It is impressive to see the lumen gain we get with minimal recoil. Our center’s three investigators have all noted similar experiences with the device.”