Cagent Vascular Initiates the Serranator® POINT FORCE Observational Registry

WAYNE, Penn.–(BUSINESS WIRE)–Cagent Vascular, Inc., the exclusive developer of serration technology for vessel dilation in endovascular interventions, today announced the start of the POINT FORCE Registry, a post-market clinical follow-up study of the Serranator^® PTA Serration Balloon Catheter.

“What we endeavor to understand In POINT FORCE is the role Serranation can play in routine clinical practice. We anticipate reviewing Iliac, Fem-Pop, Infra-Pop, and Infra-Malleolar vessel territories, along with AV Access.”

Post this

This prospective, multicenter, single-arm study will enroll a minimum of 500 subjects at up to 30 centers in the United States. The objective of this study is to evaluate the safety and efficacy, under local standard of care, of Serration Angioplasty for the treatment of Peripheral Artery Disease (PAD) throughout the entire leg.

The primary endpoint for this study is Device Success, defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device with a post- Serranator^® residual stenosis of ≤30%, as assessed by an independent angiographic core lab. Yale Cardiovascular Research Group in New Haven, CT, will serve as the corelab for this study.

Led by national co-principal investigators S. Jay Mathews, MD, MS, Director Cardiac Catheterization Laboratory, PERT & Structural Heart at Manatee Memorial Hospital in Bradenton, FL and Michael Siah, MD, Director of Limb Salvage at University of Texas Southwestern (UTSW) Medical Center in Dallas, TX, this registry will build the body of clinical evidence for Serration Angioplasty. The first POINT FORCE patient was enrolled at UTSW by Dr. Siah.

“We’re excited to launch the POINT FORCE registry with the initial enrollment here at UTSW,” Dr. Siah said, “Serranator^® is a key part of our ATK and BTK treatment algorithm, and our team is eager to analyze this large, corelab-adjudicated dataset to capture the results of treating with Serranation across a wide spectrum of treatment strategies and clinical presentations.”

“We know from prior corelab-adjudicated studies that Serranator^® provides an efficacious result for patients, with a very low rate of complication and mitigated recoil,” stated Dr. Mathews, “What we endeavor to understand In POINT FORCE is the role Serranation can play in routine clinical practice. We anticipate reviewing Iliac, Fem-Pop, Infra-Pop, and Infra-Malleolar vessel territories, along with AV Access.”

Brian Walsh, Chairman and CEO of Cagent Vascular, added, “Despite having performed over 20,000 procedures, Serranator^® remains a new and disruptive PAD therapy. We expect POINT FORCE will illuminate the benefits of Serranation and help share the impact in all common clinical algorithms. We’re excited to get started and grateful for the support of our PIs and all participating centers.”

About Cagent Vascular, Inc.

For more information, visit www.cagentvascular.com.

The Serranator^® is an FDA-cleared, novel balloon using proprietary stainless steel micro-serration technology, designed to create linear, interrupted scoring along the endoluminal surface. With 1,000x more point force compared with plain-old balloon angioplasty, serration occurs during slow-and-low balloon inflation and is designed to aid arterial expansion, effectively achieving luminal gain in all lesion morphologies.