Analysis of SAVVE Pivotal Trial Data Presented for enVVeno VenoValve

April 15, 2025—enVVeno Medical Corporation recently announced the presentation of findings from a subanalysis of the 1-year data from the prospective, multicenter SAVVE pivotal trial of the company’s VenoValve, a bioprosthetic replacement venous valve surgically implanted into the femoral vein being developed for treatment of severe chronic venous insufficiency (CVI) in the deep veins of the legs.

Cassius Iyad Ochoa Chaar, MD, presented the analysis of the data on behalf of the SAVVE clinical trial investigators at the 52nd annual symposium of the Society for Clinical Vascular Surgery (SCVS) held March 29 to April 2, 2025. Dr. Chaar is Associate Professor of Surgery at Yale School of Medicine in New Haven, Connecticut.

The 1-year SAVVE data were presented at the 51st annual VEITHsymposium held in November 2024 in New York, New York.

As summarized in enVVeno’s press release, the prospective, multicenter SAVVE trial was composed of 75 patients with severe CVI. Clinically meaningful improvement was defined as a ≥ 3-point improvement in revised Venous Clinical Severity Score (rVCSS).

The study showed that most patients with advanced venous disease experienced clinically meaningful improvement at 12 months after VenoValve implantation, with significant decrease in mean rVCSS. Additionally, improvement in clinical and patient-reported outcomes in postthrombotic syndrome and primary valvular disease were comparable and sustained. Overall, 85% of patients experienced clinically meaningful improvement irrespective of the etiology of the patient’s CVI, reported enVVeno.

The analysis presented at SCVS specifically examined the impact of the VenoValve on patients with primary etiology of their CVI versus those patients with postthrombotic etiology, noted the company.

The enVVeno press release stated that the analysis presented at SCVS demonstrated the following:

• Both primary etiology and postthrombotic etiology sustained a progressive decrease in pain, as measured by Visual Analog Scale at 12 months.
• Sustained improvements in patient-reported outcomes with respect to symptoms and quality of life were reported for both cohorts at 12 months.
• Reduction in area of ulceration was more marked in the primary valvular reflux cohort.

“The results of the SAVVE clinical trial presented at SCVS show that VenoValve is an effective treatment for patients with deep venous reflux,” commented Dr. Chaar in correspondence with Endovascular Today. “Most patients presented with ulcers with duration of more than a year and no other options for treatment. Clinical improvement is evident at 3 months and continues up to 1 year, including ulcer healing.” Also, enVVeno noted to Endovascular Today that all ulcers of less than 1-year duration showed healing within 3 months after implantation.