WAYNE, Pa.--(BUSINESS WIRE)--Vesper Medical, Inc., a developer of medical devices for deep venous disease, today announced the completion of enrollment in its pivotal study - Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent System® (VIVID).
The VIVID Trial enrolled its 160th patient earlier this month. This marks completion of enrollment in the VIVID Trial, well ahead of schedule. VIVID 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 disease location within the iliofemoral vein.
“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, Director of Clinical Trials at St. Joseph Heart and Vascular Center in Orange, California and principal study investigator.
Chronic venous insufficiency (CVI) is one of the largest burdens on health care systems in both Europe and the United States, affecting up to 35% of the adult population1. 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
“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 & CEO of Vesper Medical.
The VIVID Trial is a global study designed to enroll 160 patients at 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.
About the Vesper Duo Venous Stent System
The Vesper DUO Venous Stent System is a next generation venous technology that advances the treatment of deep venous disease. Vesper Medical’s portfolio approach enables the clinician to tailor treatment in the iliofemoral venous anatomy based on disease patterns and severity. 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.
Visit http://www.vespermedical.com for more information.
About Vesper Medical
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. Visit www.vespermedical.com for more information.
This press release contains “forward-looking statements” concerning the development of Vesper Medical's products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Vesper Medical undertakes no obligation to update any forward-looking statements for any reason.
Vesper DUO Venous Stent System®, Vesper DUO EXTEND Venous Stent System®, DUO-HYBRID™ and DUO-EXTEND™ are trademarks of Vesper Medical, Inc.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
1 http://www.veincareteam.it/chronic-venous-disease/chronic-venous-disease-numbers.html
2Davies, 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
