enVVeno’s VenoValve Evaluated in Interim 1-Year Data From SAVVE US Pivotal Trial

June 21, 2024—enVVeno Medical Corporation announced that interim venous ulcer healing data from the SAVVE trial showed significant clinical improvement with the company’s VenoValve. The data included 21 patients with 30 venous ulcers who had reached the 1-year follow-up milestone.

According to the company, SAVVE is a prospective, nonblinded, single-arm, multicenter study that enrolled 75 patients with chronic venous insufficiency at 21 sites in the United States.

SAVVE primary investigator Cassius Iyad Ochoa Chaar, MD, delivered the data in a presentation titled “The Impact of VenoValve Implantation on Venous Ulcer Healing in Patients with Deep Venous Reflux” at VAM24, the Society for Vascular Surgery’s 2024 Vascular Annual Meeting held June 19-22 in Chicago, Illinois. Dr. Chaar is Associate Professor Surgery, Yale School of Medicine, Division of Vascular and Endovascular Surgery, in New Haven, Connecticut.

As summarized in enVVeno’s press release, 91% of venous ulcer patients who were evaluated at 1 year had either fully healed ulcers or ulcers that had improved and showed the following:

• 100% of venous ulcers with a duration of ≤ 1 year before VenoValve surgery had fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery.
• 89% of venous ulcers with a duration of > 1 year before VenoValve surgery, had either fully healed or improved at 1 year, representing a decrease in average of total ulcer of 85%.
• Patients with a fully healed venous ulcer experienced no ulcer recurrence.

The company noted that venous ulcers in SAVVE were evaluated with the help of an FDA-registered scientific calibrant applied to each venous ulcer image to track wound healing over time; this technology relies on artificial intelligence to accurately measure wound circumference and progress.

The FDA has asked enVVeno to collect a minimum of 1 year of data on all SAVVE patients before filing its application for premarket approval to the FDA. The company advised that it expects to file the PMA application in Q4 of 2024.

Additional data from SAVVE is available on enVVeno’s website.