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.
Endpoints for the study include improvements in reflux time measured by duplex scans and rVCSS, VAS and VEINES scores, which are used as clinical measurements for venous disease. Hancock Jaffe said that patients in the trial will be monitored at regular intervals, with a focus on 90 and 180 day results.
The company has already won clearance in Colombia to launch the trial, looking to enroll five to 10 patients with severe chronic venous insufficiency.
“We have already received more than 100 inquiries from patients in Colombia wanting to participate in our study. Patients will be carefully screened under the supervision of Dr. Jorge Hernando Ulloa, our primary investigator in Bogota, and Dr. Marc H. Glickman, Hancock Jaffe’s chief medical officer. Because results from the study will come relatively quickly, now is the appropriate time to begin to explain the terminology that we will be using to measure our success,” CEO Robert Berman said in a press release.
Hancock Jaffe said that data from the trial will be used to make design modifications to the VenoValve in preparation for a pivotal trial of the device in the U.S