Cagent Vascular has announced the initiation of the PRELUDE-BTK study. According to a press release, the purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter in infrapopliteal arteries.
Andrew Holden (University of Auckland, Auckland Hospital, Auckland, New Zealand) is the principal investigator and seven other investigators from Austria, Germany and Poland are participating in the 48-patient trial, which will include 30-day and six-month follow up. The press release reports that the Serranator below-the-knee (BTK) device has three external metal serrated strips embedded on a semi-compliant balloon. It is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion.
Michael Lichtenberg (Klinikum Hochsauerland GmbH, Arnsberg, Germany) comments: “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 (Krankenhaus Buchholz, Buchholz, Germany) noted: “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.”
Cagent Vascular submitted the FDA 510(k) application for the infrapopliteal indication of the device was recently filed, with clearance expected later this year. Carol A Burns, president and CEO, says: “We are excited and encouraged by these early acute results which are in line with our previous experience from the PRELUDE, above-the-knee study. We believe the Serranator has the potential to change the current treatment paradigm by restoring blood flow with minimal vessel injury. In the future, we believe the Serranator could become the standard of care for BTK interventions.”