Vesper Medical Announces Initiation of Pivotal VIVID Trial for the Vesper Duo Venous Stent System

December 1, 2020—Vesper Medical, Inc. announced the initiation of VIVID, its FDA investigational device exemption (IDE) study of the company’s Vesper Duo venous stent system, with the enrollment of the first patient. VIVID is a prospective, multicenter, single-arm study designed to evaluate the safety and efficacy of the Vesper Duo stent system in the treatment of patients with iliofemoral occlusive disease. Vesper Duo is limited by United States law to investigational use.

According to the company, the trial 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 postprocedure and primary efficacy of the stented segment at 12 months. Patients enrolled in the study will be followed for 3 years.

The Vesper Duo device is designed to be a next-generation venous stent technology 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.

In the company’s announcement, Jason Yoho, MD, with the Heart & Vascular Institute of Texas in New Braunfels, Texas, commented, “We were honored to initiate this clinical investigation which holds significant potential benefits for patients with deep venous occlusive disease. 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’s lead Principal Investigator is Mahmood Razavi, MD, Director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, California. The European lead Principal Investigator is Michael Lichtenberg, MD, who is Chief Medical Officer of the angiology department at the Vascular Centre Clinic in Arnsberg, Germany.