January 7, 2020
PRELUDE-BTK Study Begins for Cagent Vascular’s Serranator PTA Balloon Catheter
January 7, 2020—Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announced the initiation of the PRELUDE-BTK study.
The purpose of the prospective, single-arm, multicenter feasibility study is to show the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in infrapopliteal arteries. The company advised that the FDA 510(k) application for the infrapopliteal indication was recently filed, with clearance expected in 2020.
The study is led by Principal Investigator Andrew Holden, MBChB, from Auckland, New Zealand. Seven other investigators from Austria, Germany, and Poland are participating in the 48-patient trial that will include 30-day and 6-month follow-up.
According to the company, the Serranator below-the-knee (BTK) device has three external metal serrated strips embedded on a semicompliant balloon. It is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion.
Trial Investigator Michael Lichtenberg, MD, from Klinikum Hochsauerland GmbH in Arnsberg, Germany, commented in the company’s announcement, “The Serranator is a novel device for calcified lesion intervention in infrainguinal vessels. Especially in BTK vessels, calcified lesions are likely to dissect or recoil after balloon angioplasty alone, which results in bad functional outcomes and low patency rates; therefore, we need to find much better ways to achieve sufficient lumen gain without significant dissections. The Serranator balloon is a promising tool to achieve a good lumen gain without recoil and dissections.”
Klaus Hertting, MD, from Krankenhaus Buchholz in Buchholz, Germany, added, “The design of the Serranator balloon, with its ability to apply very high focal force despite low balloon inflation pressure, is unique. Although its profile is naturally larger in comparison to a plain balloon, it still appears to have an acceptable crossability. It appears to be able to limit the vessel trauma to discrete serrations instead of diffuse and uncontrolled dissections and rupture of vessel structures. It might also serve as a keystone for the use of drug-eluting technology in this area.”