Cagent Vascular’s Serranator PTA Catheter Compared to POBA in Subanalysis of PRELUDE BTK Study

January 31, 2023—Cagent Vascular announced the results of a comparative subanalysis of the PRELUDE-BTK study versus plain old balloon angioplasty (POBA) in the treatment of below-the-knee (BTK) peripheral artery disease (PAD). PRELUDE-BTK is a prospective, single-arm, multicenter feasibility study of the safety and efficacy of percutaneous transluminal angioplasty (PTA) in BTK lesions with the company’s Serranator technology.

The substudy was led by Professor Marianne Brodmann, MD, of the Medical University Graz, Austria. The findings were published online in November 2022 by Katharina Guetl, MD, et al in Journal of Endovascular Therapy.

As summarized by Cagent Vascular, in the subanalysis comparing the PRELUDE-BTK subset data to a consecutive POBA group data, which were analyzed by the same independent core lab, the investigators reported the following findings:

• The Serranator-treated lesions had an average final residual stenosis of 17.2% ± 8.2% versus 33.7% ± 15.7% in the POBA group, representing a 49% average improvement in final residual stenosis.
• In chronic total occlusions, there was a 62% improvement in final residual stenosis compared to the POBA group.
• The average balloon inflation pressure was 5 atm in the Serranator group versus 9 atm in the POBA group.
• Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement versus POBA.

In January 2021, the 30-day and 6-month follow-up results from PRELUDE-BTK were presented by Coprincipal Investigator Andrew Holden, MBChB, with Auckland City Hospital in Auckland, New Zealand, at LINC 2021, the Leipzig Interventional Course, which was held as a virtual event.

According to Cagent Vascular, the FDA-cleared and CE Mark–approved Serranator PTA balloon catheter embeds serration technology into a semicompliant balloon to treat PAD. The Serranator is commercially available in various balloon lengths and diameters to treat both the above-the-knee and BTK lesions.

In the device’s mechanism of action, serrated metal strips create multiple longitudinal lines of interrupted microserrations to aid arterial expansion at low inflation pressure.

Prof. Brodmann commented in the company’s press release, “As an early user of serration angioplasty, it was meaningful to quantify through this subanalysis what we’ve experienced using the Serranator device. Dr. William Tang, PhD, Associate Dean of Research and Professor of Biomedical Engineering at UC Irvine, developed a novel model, anchored by Poiseuille’s law, from which we were able to derive the volumetric blood flow from lumen gain achieved with the Serranator compared to conventional balloon angioplasty. These results suggest an advantage for serration technology that should allow for superior wound healing and patient outcomes, while minimizing the need for stent placement.”

Raman Sharma, MD, of Mount Sinai Medical Center in New York, New York, was an early adopter of serration technology. Dr. Sharma added in the press release, “When it comes to BTK interventions, there simply haven’t been great options for physicians to treat patients who are often in jeopardy of limb loss. In these cases, our goal is to restore sufficient blood flow to allow a patient’s wound to heal, without leaving anything behind. The results from this subanalysis study support what we have seen in our experience; the Serranator provides greater lumen gain and blood flow versus conventional technology.”