US medical devices manufacturer Cagent Vascular has initiated the PRELUDE-BTK trial to evaluate the safety and efficacy of its Serranator PTA Serration Balloon Catheter in infrapopliteal arteries.

The company develops advanced angioplasty balloons using its original serration technology for the treatment of diseased peripheral arteries.

The PRELUDE-BTK clinical trial will be conducted by eight investigators from New Zealand, Austria, Germany, and Poland, and includes follow up at 30 days and 6 months.

Study investigator Michael Lichtenberg said: “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.”

According to the company, patients with peripheral artery disease (PAD), specifically with BTK arteries, are often under served and under diagnosed.

Serranator BTK device has three external metal serrated strips

Cagent has designed its Serranator BTK device with three external metal serrated strips embedded on a semi-compliant balloon, to create several longitudinal lines of interrupted micro-serrations for arterial expansion.

In addition, the device is capable of applying high focal force, regardless of low balloon inflation pressure, and preventing vessel trauma to discrete serrations, to avoid uncontrolled dissections and rupture of vessel structures.

Furthermore, the company has filed an application with the FDA 510(k) for infrapopliteal indication, and the approval is expected later in 2020.

Cagent Vascular president and CEO Carol A Burns said: “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.”