FDA Awards IDE for Pivotal Study of enVVeno’s Venous Valve to Treat Severe Deep CVI

April 29, 2026—enVVeno Medical Corporation announced it has received an FDA investigational device exemption (IDE) for the pivotal study of the company’s enVVe transcatheter venous valve endoprosthesis (TAVVE) in the United States. The TAVVE study will evaluate the enVVe device in the treatment of patients with severe deep chronic venous insufficiency (CVI).

According to the company, the first stage of the TAVVE study, which is expected to commence later this year, will be composed of 10 patients. The 30-day safety results from these patients will be submitted to the FDA for review.

This initial group of 10 patients will continue to be followed as a separate cohort throughout the study with their safety and efficacy data reported publicly from time to time, advised the company.

The second stage of the study will begin immediately after the 30-day safety results for the first group are reported to the FDA. In this stage, the study investigators will enroll 220 patients at up to 40 clinical sites in the United States. These patients will be randomized to receive either the enVVe device (n = 165) or a control arm receiving standard-of-care treatment (n = 55 patients). The company noted that the study investigators will include vascular surgeons, interventional radiologists, and interventional cardiologists.

The company will be eligible to file for FDA premarket approval at 1 year after the 220th patient is enrolled in the second stage of the study, advised enVVeno.