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enVVeno Medical has received FDA investigational device exemption (IDE) approval to begin the pivotal TAVVE trial of its enVVe system, a minimally invasive transcatheter replacement venous valve for patients with severe deep chronic venous insufficiency (CVI).
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The study is expected to enroll approximately 230 patients across up to 40 U.S. sites, evaluating the first-in-class, non-surgical device designed to offer a treatment option for patients with limited alternatives. The company also announced a new U.S. patent covering key components of the enVVe system.
“The second quarter represented a defining milestone for enVVeno, as we got the approval to move forward with the pivotal study for enVVe, our non-surgical replacement venous valve,” said CEO Rob Berman. “enVVe has the potential to completely change the treatment trajectory for the 3 million U.S. patients that suffer from severe, deep venous CVI and have no effective treatment options.”
