Cagent Vascular Announces FDA 510(k) Clearance for its Serranator Device for the Infrapopliteal Indication and Completion of its PRELUDE-BTK Clinical Trial Enrollment
WAYNE, Pa.–(BUSINESS WIRE)–
Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions.
The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). It is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
The company also recently completed enrollment of its PRELUDE-BTK Study, a prospective, single-arm, multi-center feasibility study to show the safety and efficacy of the device. A total of 49 patients were enrolled. The study is led by Principal Investigator, Dr. Andrew Holden (Auckland, New Zealand). Six centers from Europe and New Zealand are participating in the trial which will include 30-day and 6-month follow up.
“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,” stated Dr. Holden.
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