The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said. Reflux is the primary end point for HJLI’s ongoing VenoValve trial first-in-human clinical trial in Bogota, Colombia, and is the main cause of severe chronic venous insufficiency (CVI) of the deep vein system.
Principal investigator Dr. Jorge Hernando Ulloa reported that overall, reflux has been reduced an average of 68% across all patients with the working VenoValve device, compared with the 45% reduction that was reported in June, when patients were 60 days post-surgery. Venous clinical severity scores, which measure venous disease severity graded by the clinician, has also continued to improve, with the average improvement across all four patients now at forty-nine percent (49%), compared to pre-operative levels, the company said. Pain across the patients decreased 39%. Ulloa reported the data at the second annual Society of Vascular and Endovascular Surgery Congress of Central America and the Caribbean.
“Our 90-day data shows substantial improvement in our patients in all important areas. In addition, we have not experienced any significant device related adverse events,” said HJLI CEO Robert Berman in a news release. “At this point, the results that we are seeing with the VenoValves is exceptional.”
HJLI expects to release 180-day results for these patients, and incremental results for other patients enrolled in the study, in October. The company expects to use the data from its first-in-man Bogota study as part of an investigational device exemption application, to be submitted to the the FDA in early 2020.