ANN ARBOR–In a first-in-human, compassionate use case approved by the U.S. Food and Drug Administration, University of Michigan Health interventional radiologists David M. Williams and inhaj S. Khaja successfully used a new medical device from an Israeli firm, VeinWay, calleds Traversa for venous recanalization 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 recanalize a previously uncrossable vascular pathway, which included a 20-centimeter-long (7.9-inch) blocked vein with four occluded stents.
Said Williams: “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 desperate condition. Traversa not only made this procedure possible, but also much easier and impressively faster.”
Added Khaja: “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. 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.”
And Jordan Pollock, VeinWay CEO, said: “Our mission is to give surgeons the control they need to recanalize the veins of their patients safely, timely and successfully. In doing so, we hope to inspire physicians to perform more venous recanalizations 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 recanalization. We would like to thank the 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 honored to be of service.”
Michigan Medicine serves 2.3 million outpatient visits a year, and includes UM Medical School and University of Michigan Health, which includes the C.S. Mott Children’s Hospital, Von Voigtlander Women’s Hospital, University Hospital, the Frankel Cardiovascular Center, Kellogg Eye Center, University of Michigan Health West and the Rogel Cancer Center. More at www.med.umich.edu/.
VeinWay provides physicians with a dedicated, purpose-built tool to create a pathway through a clogged vein such that physicians can easily restore blood flow through the vein to the heart. This tool is built to expand the physician’s ability to safely cross a variety of complicated blockages that were previously un-crossable, as well as shorten the time to cross. The company addresses an annual market of more than 1.7 million deep vein thrombosis patients, half of whom will return with post thrombotic syndrome within three to five years and 68% of those will have fully blocked veins. Traversa was developed by VeinWay as part of the MEDX Xelerator’s Entrepreneur-in-Residence program designed to promote breakthrough innovation. VeinWay 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 (CBG), and West Pharmaceuticals. The company is currently engaged in an A financing round.
The photo above shows Jordan Pollack, CEO of Veinway, left, and Minhaj S. Khaja on the day of the procedure.