VeinWay’s Traversa Device for Venous Recanalization Completes FIH Compassionate Use Procedure

March 2, 2023—VeinWay announced the completion of a first-in-human (FIH), compassionate-use procedure approved by the FDA that used the company’s Traversa device for venous recanalization to save a patient’s leg that was close to being amputated.

According to VeinWay, Traversa is a newly developed tool for crossing tough occlusions in veins. The device enabled the physicians to recanalize a previously uncrossable vascular pathway, which included a 20-cm long blocked vein with four occluded stents.

The procedure was successfully performed by University of Michigan Health Interventional Radiologists David M. Williams, MD, and Minhaj S. Khaja, MD, at University of Michigan Health in Ann Arbor, Michigan.

“I had crossed the segment in this patient 3 years ago, but today it would have been impossible with existing devices,” commented Dr. Williams in the company’s press release. “The patient’s leg was in desperate condition. Traversa not only made this procedure possible, but also much easier and impressively faster.”

Dr. Khaja added, “The device allowed us to take the path that we wanted rather than being forced to trouble shoot the path chosen by the sharp recanalization devices available today.” He explained further, “With Traversa, we were able to choose the angle and the length of the throw of the needle. This enabled us to pick the pathway and if we didn’t like it, we were able to readjust. I think that allowed us to safely get through the occlusions and the stents.”

VeinWay, which is based in Or Yehuda, Israel, is a portfolio company of the MedX Xelerator, a medical device incubator backed by Boston Scientific, Sheba Medical Center, MedX Ventures Group, Consensus Business Group, and West Pharmaceuticals.