Vesper Medical Completes Enrollment in VIVID Clinical Trial

The final patient has been enrolled in Vesper Medical Inc.’s study of its Venous stent.

Enrollment in the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent System (VIVID) finished well ahead of schedule, according to the company.  VIVID is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of the Vesper DUO Stent System in treating patients with iliofemoral occlusive disease. “The rapid enrollment of the VIVID Trial is a testimonial to the magnitude and severity of chronic venous insufficiency and the dedication of our investigators and employees. We are thrilled to take this important step toward bringing the novel DUO-HYBRID and DUO-EXTEND venous stent technology to patients suffering with CVI,” said Bruce J. Shook, president and CEO of Vesper Medical.

The Vesper DUO Stent System is 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 disease location within the iliofemoral vein. The DUO-HYBRID stent has a distinct integrated design that changes along its length from high crush resistance in the iliac region to high flexibility in the pelvic region, thus targeting the dynamic loading conditions in the iliofemoral venous system. The DUO-EXTEND stent is engineered to smoothly integrate with the DUO-HYBRID stent to provide physicians the flexibility to treat longer lesions.

The VIVID Trial is a global study of 160 patients at U.S. and European centers that will assess freedom from major adverse events at 30 days post-procedure and primary efficacy of the stented segment at 12 months. The study will follow patients enrolled in the study for three years. 

“I would like to thank all of the investigators and their teams for the commitment, skill and hard work they brought to the VIVID Trial. This has been a tremendous team effort that will ultimately benefit the millions of patients who suffer today with chronic venous insufficiency,” said Dr. Mahmood Razavi, principal study investigator and director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, Calif.
 
Chronic venous insufficiency (CVI) is one of the largest burdens on healthcare systems in both Europe and the United States, affecting up to 35 percent of the adult population.¹ CVI can manifest in multiple ways, the most severe forms resulting in skin changes and ulcers, leading to poor quality of life for patients as well as life threatening complications like acute deep vein thrombus formation.²
 
Vesper Medical is a privately held medical device company that develops minimally- invasive peripheral vascular products, with a focus on advancing and improving the treatment of deep venous disease. 

References 
¹ http://www.veincareteam.it/chronic-venous-disease/chronic-venous-disease-numbers.html
² Davies, A.H. The Seriousness of Chronic Venous Disease: A Review of Real-World Evidence. Adv Ther 36, 5–12 (2019). https://doi.org/10.1007/s12325-019-0881-7