WAYNE, Pa.– Cagent Vascular, the exclusive developer of Serration Angioplasty (Serranator®), announced the results of a comparative sub-analysis of the PRELUDE-Below-the-Knee (BTK) study versus Plain Old Balloon Angioplasty (POBA). The study was led by Dr. Marianne Brodmann (Radcliffe Cardiology, Graz, Austria). This sub-analysis compared their PRELUDE-BTK subset to a consecutive POBA group. The Serranator-treated lesions had an average final residual stenosis of 17.2 +/- (8.2%) versus 33.7 +/- (15.7%) in the POBA group. This represents a 49% average improvement in final residual stenosis. In Chronic Total Occlusions (CTO), 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 conventional balloon angioplasty group. Additionally, Serranator-treated arteries demonstrated 2.4 times greater calculated flow improvement versus POBA. These data, analyzed by the same independent core lab, were recently published in the Journal of Endovascular Therapy.
Angioplasty is the most common treatment for tibial lesions; however, it often has limitations such as inadequate lumen expansion, flow-limiting dissections, and the need for reintervention. The Serranator PTA Serration Balloon Catheter is the first and only angioplasty balloon that embeds Serration Technology into a semi-compliant balloon for treating Peripheral Artery Disease (PAD). The Serranator’s mechanism of action is unique in that the serrated metal strips create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion at low inflation pressure. The Serranator is commercially available in various balloon lengths and diameters to treat both the above-the-knee and below-the-knee lesions.
Dr. Marianne Brodmann stated, “As an early user of Serration Angioplasty, it was meaningful to quantify through this sub-analysis what we’ve experienced using the Serranator device. Dr. William Tang (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.”
Dr. Raman Sharma (Mount Sinai Medical Center, New York, NY) was an early adopter of Serration Technology, and added, “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 sub-analysis study support what we have seen in our experience; the Serranator provides greater lumen gain and blood flow versus conventional technology.”
Carol A. Burns, President and CEO of Cagent Vascular stated, “Peripheral Artery Disease (PAD), and especially Chronic Limb-Threatening Ischemia (CLTI), is well-recognized as a major contributor to poor quality of life, amputation, and even death, resulting in an enormous economic burden. The Serranator’s acute results showed a meaningful improvement over conventional therapy. We believe Serration Technology is the long-awaited revolutionary advancement needed for angioplasty,” Burns added.
