Hancock Jaffe implants four VenoValves in first-in-human study
Hancock Jaffe (NASDAQ:HJLI) has implanted VenoValves in four patients with severe, chronic venous insufficiency (CVI) as part of its first-in-human study of the device.
CVI occurs when the valves in the veins of the leg are compromised, causing blood to flow backward and pool in the lower extremities. CVI results in increased venous pressure and can cause significant disability when severe.
"It is amazing to observe these surgeries, and then watch our patients get up and walk less than two hours after the procedure. The patients are very appreciative to receive a device that could potentially reduce or eliminate the debilitating symptoms from chronic venous insufficiency," Robert Berman, Hancock Jaffe's CEO, said in a statement.
The study will enroll five-to-10 CVI patients who will undergo duplex scans to evaluate VenoValue’s reduction of deep venous reflux.
Hancock Jaffe is conducting this first-in-human study in Colombia prior to a pivotal trial in the U.S. based on feedback from the FDA. The company expects preliminary data from the first group of patients in June 2019.