MALVERN, PA — Vesper Medical, Inc., a developer of medical devices for deep venous disease, announced initiation of its U.S. Food and Drug Administration (FDA) Investigational Exemption (IDE) study – Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent System® (VIVID).
The VIVID Trial, which enrolled its first patient yesterday, is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of the Vesper DUO Stent System in the treatment of patients with iliofemoral occlusive disease. The Vesper DUO Stent System is designed to be the next generation venous stent technology, uniquely engineered to address the challenges of deep vein obstruction. The modular portfolio is intended to provide physicians clinical versatility with both the DUO HYBRID™ and DUO EXTEND™ stent options in a full range of lengths and diameters to customize therapy for each patient depending on their specific stenosis location within the iliofemoral vein.
“We were honored to initiate this clinical investigation which holds significant potential benefits for patients with deep venous occlusive disease,” said Dr. Jason Yoho of the Heart & Vascular Institute of Texas, New Braunfels, TX. “Until now, we haven’t had a portfolio of stents that have been uniquely tailored to the venous anatomy and can be customized to meet each patient’s need.” The study is led by lead principal investigator Dr. Mahmood Razavi, Director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, California, and European lead principal investigator Dr. Michael Lichtenberg, Chief Medical Officer of the Angiology department at the Vascular Centre Clinic in Arnsberg, Germany.
The role of obstruction in the deep venous system is increasingly recognized as a major cause of chronic venous disease. It is estimated that more than 30 million adults in the United States have some form of venous disease, with Chronic Venous Insufficiency (CVI) being a common health problem occurring in up to 5% of the population.1 A person with CVI can experience symptoms like severe swelling, pain, or even skin discoloration and ulcers. Venous obstruction can occur as a result of different causes, including extrinsic compression because of malignancy or anatomic variation, and acute or chronic Deep Vein Thrombosis (DVT).
“Commencement of patient enrollment in the VIVID Trial is a critical milestone in the development of the Vesper DUO Stent System, said Bruce J. Shook, President & CEO of Vesper Medical. “The unmet need in the treatment of deep venous disease is enormous, and we are excited to bring the next generation in venous stenting technology to patients in need.”
The VIVID Trial is a global study and will enroll up to 160 patients in up to 45 centers in the United States and Europe. It will assess freedom from major adverse events at 30 days post-procedure and primary efficacy of the stented segment at 12 months. Patients enrolled in the study will be followed for 3 years. More information can be found on clinicaltrials.gov/NCT04580160
- Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, et al. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May; 53(5 Suppl):2S-48.
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