I-Vasc Begins Postmarket Trial of CE Mark–Approved Velex Empty Vein Ablation Technology for CVI

June 14, 2022—I-Vasc, a Milan, Italy–based start-up company, announced the initial clinical use of the CE Mark–approved Velex system, which the company developed for the treatment of chronic venous insufficiency (CVI). The first two cases were performed at the Policlinico San Donato center in Milan, Italy.

These first cases represent the start of the V.A.S.C. postmarket multicenter clinical trial that will be coordinated by Policlinico San Donato, where Paolo Righini, MD, will serve as the trial’s Principal Investigator. Patients will also be enrolled at San Raffaele Hospital in Milan and other international sites.

According to the company, the Velex catheter system performs sclerotherapy based on the empty vein ablation (EVA) concept, which was invented and developed by vascular surgeon Mario Salerno, MD, who is the I-Vasc Founder and Chairman of the Board.

The EVA technology allows for fully controlled application of the sclerosant drug in the segment of vein to be treated. Before injection of the drug, this segment is emptied from blood and isolated from the rest of the venous system. The quick procedure is intended to increase both the efficacy and safety of sclerotherapy.

“We have been following the development of this technology for a while, and we were very interested in verifying its clinical performance,” commented Dr. Righini in the company’s press release. “Velex is based on a simple and elegant concept that has the potential to make endovascular chemical ablation more effective from every point of view, especially for patients with larger vessels, such as the large saphenous veins treated today in this study. These veins would be the most challenging for current sclerotherapy. They would perhaps be alternatively treated with thermal/mechanical ablation that, however, requires the use of anesthesiology drugs because of considerable intraprocedural discomfort.”

Dr. Righini added, “While only follow-up on all the approximate 30 patients to be enrolled in the study will provide sufficient data for an adequate evaluation, the procedural success and the short-term evidence give us hope for the best.”