Veniti Completes First Use of CE Mark Approved Vici Verto Venous System

April 21, 2016—Veniti, Inc. announced the initial use of the company’s Vici Verto venous stent system for the successful treatment of a patient with postthrombotic syndrome associated with venous outflow obstruction. The stent delivery system allows the physician to deploy a venous stent beginning at the peripheral end of the common femoral vein. The procedure was performed by Stephen Black, MD, Consultant Vascular Surgeon at Guy’s and St. Thomas’ NHS Foundation Trust in London, United Kingdom. 

The Vici Verto received European CE Mark approval on April 1, 2016, and is commercially available in Europe. The company previewed the device at the Charing Cross Symposium in London, United Kingdom, along with the previously released Vici venous stent.

In Veniti’s press release, Dr. Black commented, “Frequently, in patients with extensive venous outflow obstruction causing postthrombotic syndrome, it is necessary to extend the stents below the inguinal ligament to cover the entirety of the common femoral vein. In these cases, accurate stent placement is essential to maintain inflow to the stent system from both the profunda and femoral veins. It is encouraging to see the team at Veniti and others in the industry working with physicians to develop new products like the Vici Verto venous stent which address the specific needs of the physicians treating venous disease.”

The VIRTUS trial is being performed under a US Food and Drug Administration investigational device exemption to evaluate the safety and efficacy of the Vici venous stent for the treatment of chronic iliofemoral venous outflow obstruction. The Vici venous stent is approved and commercially available in the European Union and Australia. The device is not approved in the United States, advised the company.