enVVeno’s VenoValve Shows Sustained Benefit for CVI in 3-Year FIH Data

November 17, 2022—enVVeno Medical Corporation announced long-term, 3-year observational data from a cohort of patients who participated in the company’s concluded VenoValve first-in-human (FIH) clinical trial.

The surgically implanted VenoValve is intended to restore proper directional blood flow for patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The findings showed that the VenoValve patients, who are now an average of 36 months postimplantation, continue to benefit from treatment with the device.

The study’s Principal Investigator, Jorge Hernando Ulloa, MD, presented the data at the 49th annual VEITHsymposium, held November 15-19 in New York, New York.

According to the company, the patients in the study have experienced no relapses of severe CVI and no recurrences of venous ulcers. Safety events were limited to one thrombosis after discontinuation of anticoagulation medication.

The average improvements in reflux, CVI disease manifestations (revised Venous Clinical Severity Score [rVCSS]), and pain (Visual Analogue Scale) remained stable at 63%, 52%, and 84%, respectively, when compared to presurgery levels, for the cohort of eight patients that agreed to be followed at conclusion of the 1-year FIH trial. One patient experienced an increase in rVCSS caused by dermatitis, which is unrelated to the VenoValve or vascular disease.

The average age of the patient group was 68 years, including one patient who is now 89 years and another patient that is now 85 years of age.

In February 2022, the 30-month data from the VenoValve FIH trial were presented at the 34th annual meeting of the American Venous Forum in Orlando, Florida.

In October 2021, enVVeno, formerly known as Hancock Jaffe Laboratories, Inc., announced the commencement of the SAVVE United States pivotal trial, which is currently evaluating the VenoValve.

In addition to the surgically implanted VenoValve, which is the company’s lead product, enVVeno noted that it is developing enVVe, a nonsurgical, transcatheter-based replacement venous valve for the treatment of deep venous CVI. Both the VenoValve and enVVe are designed to act as one-way valves to help assist in propelling blood up the leg and back to the heart and lungs. The company is waiting for regulatory approval to begin the TAVVE FIH trial for enVVe.