Vesper Medical has completed subject enrolment in the pivotal VIVID clinical trial of the Vesper Duo Venous Stent System.
Designed to be a next generation venous technology, the stent system is developed to advance the deep venous disease treatment for patients with chronic venous insufficiency (CVI).
It comprises a portfolio of self-expanding venous stents, DUO-HYBRID and DUO-EXTEND, which are designed to improve luminal diameter in symptomatic venous outflow obstructions.
Providing clinical versatility, the new device allows physicians to customise the therapy for patients depending on their specific disease location in iliofemoral vein.
The multi-centre, prospective, single-arm, global study has enrolled 160 participants at centres in Europe and the US.
It will assess the Vesper DUO Stent System’s safety and efficacy to treat patients suffering with iliofemoral occlusive disease.
Vesper Medical president and CEO Bruce Shook said: “The rapid enrolment 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.”
According to the company, up to 35% of the adult population in Europe and the US are affected by CVI.
The company stated that the VIVID Trial will evaluate Vesper DUO venous stent system’s freedom from major adverse events (MAEs) at 30 days post procedure and the stented segment’s primary efficacy will be assessed at 12 months.
Furthermore, the participants enrolled in the study will be followed for three years.
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