enVVeno Medical’s VenoValve to Be Evaluated in SAVVE Pivotal Trial for Surgical Treatment of CVI

October 22, 2021—enVVeno Medical Corporation, formerly known as Hancock Jaffe Laboratories, Inc., announced the commencement of a United States pivotal trial for the company’s VenoValve, which is intended to restore proper directional blood flow for patients with chronic venous insufficiency (CVI) of the deep veins of the leg.

SAVVE is a prospective, nonblinded, single-arm, multicenter pivotal trial designed to evaluate the safety and efficacy of VenoValve to improve lower leg blood flow, alleviate symptoms, and improve quality of life for patients with CVI caused by dysfunctional valves in the deep veins of the lower leg. The company expects to enroll 75 patients at up to 20 centers in the United States.

The trial’s primary safety endpoint is the absence of material adverse events (MAEs) in ≤ 26% of patients at 30 days postimplantation of VenoValve. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis, or pulmonary embolism.

The primary effectiveness endpoint is improvement of reflux of ≥ 30% at 6 months after VenoValve implantation. Secondary endpoints include improvements in Venous Clinical Severity Score and visual analog scale measurements.

The first implantation in the trial was performed by Adriana Laser, MD, Associate Professor of Surgery at Albany Medical College and vascular surgeon with Albany Med Vascular Surgery in Albany, New York. The patient has been discharged from the hospital.

“It is an honor to be the first surgeon in the United States to implant a device [that] has the potential to help the millions of people [with] debilitating impacts of CVI,” commented Dr. Laser in the company’s announcement. “Although the name CVI may not be familiar to the general public, deep venous CVI has been frustrating the vascular community and our CVI patients for decades, and we are hopeful that the VenoValve will be the first safe and effective treatment option for the disease.”

In August 2021, the 2-year postimplantation data from the first-in-human trial of the VenoValve were presented by Principal Investigator Jorge Ulloa, MD, at the Society for Vascular Surgery’s 2021 Vascular Annual Meeting. On August 3, the company announced that the FDA granted Breakthrough Device designation for the VenoValve.

The rebranding of the company from Hancock Jaffe to enVVeno Medical Corporation was announced on October 1, 2021. The company’s website is now www.envveno.com.