enVVeno’s VenoValve Evaluated in First-in-Human Data for CVI Treatment

February 25, 2022—enVVeno Medical Corporation announced that 30-month, first-in-human data for the company’s VenoValve device showed patients experienced no relapses of severe chronic venous insufficiency (CVI), no recurrences of venous ulcers, and no material adverse safety events. The data are from the eight first-in-human patients who agreed to be followed for the study, including one patient who is now 3 years postimplantation of VenoValve.

The findings were presented at the 34th Annual Meeting of the American Venous Forum (AVF) held February 23-26, 2022, in Orlando, Florida.

According to the company, the data include an average improvement in reflux of 55%, average improvement in Venous Clinical Severity Score of 61%, and average improvement in Visual Analogue Scale of 81% with VenoValve compared to pretreatment levels. enVVeno has made the slide presentation from AVF available on the Scientific Publications and Presentations page of the company’s website.

enVVeno stated that the VenoValve is being developed to be surgically implanted into the femoral vein for the treatment of deep venous CVI. The device is designed to act as a one-way valve to help restore proper blood flow up the leg to return sufficient blood back to the heart and lungs for reoxygenation.

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.

The primary safety endpoint for SAVVE is the absence of material adverse safety events in ≤ 26% of patients at 1 month postimplantation. The SAVVE primary effectiveness endpoint is improvement in reflux ≥ 30% at 6 months postimplantation of the VenoValve, stated the company.