Cagent Initiates POINT FORCE Registry of Serranator PTA Catheter

January 28, 2025—Cagent Vascular, Inc., a developer of serration technology for vessel dilation in endovascular interventions, announced the start of the POINT FORCE registry, a postmarket clinical follow-up study of the company’s Serranator percutaneous transluminal angioplasty serration balloon catheter.

According to the company, the prospective, multicenter, single-arm POINT FORCE study will enroll a minimum of 500 patients at up to 30 centers in the United States, building the body of clinical evidence for serration angioplasty.

The study’s objective is to evaluate the safety and efficacy, under local standard of care, of serration angioplasty for the treatment of peripheral artery disease throughout the entire leg.

Cagent advised that 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. The core lab for this study is Yale Cardiovascular Research Group in New Haven, Connecticut.

The study is led by National Coprincipal Investigators S. Jay Mathews, MD, and Michael Siah, MD. Dr. Matthews is Director, Cardiac Catheterization Laboratory, PERT & Structural Heart at Manatee Memorial Hospital in Bradenton, Florida. Dr. Siah, who enrolled the first patient in the POINT FORCE registry, is Director of Limb Salvage at University of Texas Southwestern (UTSW) Medical Center in Dallas, Texas.

“We’re excited to launch the POINT FORCE registry with the initial enrollment here at UTSW,” commented Dr. Siah in the company’s press release. “Serranator is a key part of our above-the-knee and below-the-knee treatment algorithm, and our team is eager to analyze this large, core lab–adjudicated data set to capture the results of treating with serranation across a wide spectrum of treatment strategies and clinical presentations.”

Dr. Matthews added, “We know from prior core lab–adjudicated studies that Serranator provides an efficacious result for patients, with a very low rate of complication and mitigated recoil. 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 inframalleolar vessel territories, along with arteriovenous access.”

Cagent stated that the Serranator is an FDA-cleared balloon using stainless steel microserration technology to create linear, interrupted scoring along the endoluminal surface. Serration occurs during slow-and-low balloon inflation to aid arterial expansion, effectively achieving luminal gain in all lesion morphologies, noted the company.