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Cagent Vascular Launches 500-Patient Registry to Evaluate Serranator® Balloon Technology for PAD Treatment

• Cagent Vascular initiates POINT FORCE Registry, a multicenter study across 30 U.S. centers to evaluate their Serranator® PTA Serration Balloon Catheter in treating peripheral artery disease.

• The prospective registry will assess device safety and efficacy in real-world clinical settings, with Yale Cardiovascular Research Group serving as the core laboratory for analysis.

• First patient enrollment completed at UT Southwestern Medical Center, with the study targeting various vessel territories including iliac, fem-pop, and infra-malleolar regions.

Cagent Vascular has launched a significant post-market clinical follow-up study to evaluate their innovative serration balloon angioplasty technology in real-world settings. The POINT FORCE Registry, initiated in January 2025, will examine the Serranator® PTA Serration Balloon Catheter's performance in treating Peripheral Artery Disease (PAD) throughout the lower extremities.

Study Design and Objectives

The prospective, multicenter, single-arm registry aims to enroll a minimum of 500 patients across 30 United States centers. The study's primary endpoint focuses on device success, which researchers define as successful delivery, balloon inflation and deflation, and retrieval of the device with a post-Serranator® residual stenosis of ≤30%. The Yale Cardiovascular Research Group in New Haven, Connecticut, will provide independent angiographic core laboratory analysis of the results.

Leadership and Clinical Perspectives

The registry is being led by two distinguished co-principal investigators: Dr. S. Jay Mathews, Director of Cardiac Catheterization Laboratory, PERT & Structural Heart at Manatee Memorial Hospital in Bradenton, Florida, and Dr. Michael Siah, Director of Limb Salvage at University of Texas Southwestern (UTSW) Medical Center in Dallas, Texas.
Dr. Siah, who enrolled the registry's first patient at UTSW, expressed enthusiasm about the study: "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."

Clinical Applications and Expected Outcomes

The registry will evaluate the technology's effectiveness across multiple vascular territories, including iliac, fem-pop, infra-popliteal, and infra-malleolar vessels, as well as arteriovenous access sites. Dr. Mathews highlighted the importance of understanding Serranation's role in routine clinical practice, noting that previous core lab-adjudicated studies have demonstrated the device's efficacy with low complication rates and reduced vessel recoil.
The POINT FORCE Registry represents a significant step in building comprehensive clinical evidence for serration angioplasty technology, potentially offering new insights into its real-world applications for PAD treatment.
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