WAYNE, PA — Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces the initiation of the PRELUDE-BTK Study.
The purpose of this prospective, single-arm, multi-center feasibility study is to show the safety and efficacy of the Serranator® PTA Serration Balloon Catheter in infrapopliteal arteries. The study is led by Principal Investigator, Dr. Andrew Holden (Auckland, New Zealand). Seven other investigators from Austria, Germany and Poland are participating in the 48 subject trial which will include 30-day and 6-month follow up.
The Serranator 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.
“The Serranator is a novel device for calcified lesion intervention in infra-inguinal vessels. Especially in ‘Below-the-Knee’ (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,” said investigator Dr. Michael Lichtenberg (Klinikum Hochsauerland GmbH, Arnsberg, Germany).
Dr. Klaus Hertting (Krankenhaus Buchholz, 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.”
Peripheral Artery Disease (PAD) continues to be a growing concern, particularly in BTK arteries where patients are underserved and under-diagnosed. The increase in diabetes, obesity and sedentary lifestyles are compounding this global problem. Cagent Vascular is committed to finding a solution to improving the lives of patients suffering from PAD. The FDA 510(k) application for the infrapopliteal indication was recently filed with clearance expected later this year.
“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,” stated Carol A. Burns, President and CEO.
Source: Cagent Vascular, 150 Strafford Ave #315, Wayne PA 19087
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