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.
Hancock Jaffe said that the first patient in the Bogota, Colombia-based trial was walking a day after surgery and that the VenoValve appears to “be functioning as it should” with no early signs of thrombosis, reflux or other adverse events.
The trial aims to enroll an initial 5 to 10 patients with severe, deep venous chronic venous insufficiency. Patients in the trial will be implanted with the VenoValve and monitored out to six months with duplex scans to measure reflux time.
Endpoints for the study, which were announced last month, 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.
“We are so excited to get our VenoValve study underway and are thrilled that the first patient is doing so well. We will continue to monitor the patient for the next few weeks and then proceed with additional VenoValve implantations,” CEO Robert Berman said in a press release.
Hancock Jaffe said it plans to release preliminary data from the first group of VenoValve recipients during the second quarter of 2019, with patients continuing to be monitored out to six months.