Vesper Medical recently announced initiation of its US Food and Drug Administration (FDA) investigational device exemption (IDE) study—VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system).
The VIVID trial is a prospective, multicentre, single-arm study to evaluate the safety and efficacy of the Vesper Duo stent system in the treatment of patients with iliofemoral occlusive disease.
According to a press release, 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 customise therapy for each patient depending on their specific stenosis location within the iliofemoral vein.
“We were honoured to initiate this clinical investigation which holds significant potential benefits for patients with deep venous occlusive disease,” said Jason Yoho of the Heart & Vascular Institute of Texas, New Braunfels, USA. “Until now, we have not had a portfolio of stents that have been uniquely tailored to the venous anatomy and can be customised to meet each patient’s need.”
The study is led by lead principal investigator Mahmood Razavi, director of clinical trials at St Joseph Heart and Vascular Center in Orange, USA, and European lead principal investigator Michael Lichtenberg, chief medical officer of the Angiology department at the Vascular Centre Clinic in Arnsberg, Germany.
“Commencement of patient enrolment in the VIVID trial is a critical milestone in the development of the Vesper Duo stent system,” said Bruce J Shook, president and 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 enrol up to 160 patients in up to 45 centres in the USA 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 three years.