Walk Vascular's Jeti Thrombectomy System Approved in United States and Europe
June 21, 2017—Walk Vascular, LLC announced US Food and Drug Administration clearance and European CE Mark approval of its Jeti thrombectomy system, which is indicated for use in the peripheral vasculature. The company has begun a limited commercial release of the 8-F catheter in North America and Western Europe, with plans for additional catheter lengths and sizes for a wide variety of procedures.
According to Walk Vascular, the Jeti catheter's focused saline jet is positioned within the distal catheter tip to macerate and aspirate thrombus from target vessels without resultant hemolysis. Jeti also features the company's Clot Detect sensing that audibly communicates aspirate flow status and is designed to improve procedural efficiency and minimize blood loss.
The HyperPulse feature, which has received CE Mark approval and is only being released in Europe, enables intraprocedural thrombolytic infusion.
The-Bao Bui, MD, commented in the company's press release, "Jeti has changed my approach to thrombus." Mahmood Razavi, MD, added, "Jeti supports the preferred approach to thrombus—single session treatment, with the goal of least postprocedure thrombolytics and maximal clot clearance. Jeti is a very safe next-generation device taking a large step in that direction.” Dr. Bui is an endovascular specialist at CHU Sherbrooke in Sherbrooke, Quebec. Dr. Razavi is an endovascular and interventional specialist at St. Joseph’s Hospital in Orange, California.