In a first-in-human, compassionate use case approved by the US Food and Drug Administration (FDA), University of Michigan Health (Ann Arbor, USA) interventional radiologists David M Williams and Minhaj S Khaja successfully used VeinWay’s Traversa for venous recanalisation to save a patient’s leg that was close to being amputated.
Traversa, a newly developed tool for crossing tough occlusions in veins, enabled the physicians to recanalise a previously uncrossable vascular pathway, which included a 20cm-long blocked vein with four occluded stents.
Williams made the following comment on the procedure—“I had crossed the segment in this patient three years ago, but today it would have been impossible with existing devices. The patient’s leg was in a desperate condition. Traversa not only made this procedure possible, but also much easier and impressively faster.”
Khaja said that “the device allowed us to take the path that we wanted rather than being forced to troubleshoot the path chosen by the sharp recanalisation devices available today. 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 did not like it, we were able to readjust. I think that allowed us to safely get through the occlusions and the stents.”
VeinWay CEO Jordan Pollack stated that his company’s “mission is to give surgeons the control they need to recanalise the veins of their patients safely, in a timely manner, and successfully. In doing so, we hope to inspire physicians to perform more venous recanalisations for the patients that need it to relieve pain and improve mobility. The procedure at University of Michigan Health was a huge step in changing the medical landscape of venous recanalisation. We would like to thank the US FDA for approving the use of Traversa in this first compassionate use case as well as Drs Williams and Khaja for their agreement to try something new. We were honoured to be of service.”