enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a pivotal study involving a non-surgical replacement venous valve. The approval allows enVVeno Medical to begin the Transcatheter Venous Valve Endoprosthesis (TAVVE) pivotal study of its enVVe system for treating severe deep chronic venous insufficiency (CVI).
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In a company press release, enVVeno Medical CEO Robert Berman said: “We have been working very closely with the FDA to ensure that the TAVVE study is structured to provide everything that the FDA wants to see in evaluating the safety and efficacy of enVVe and that we are in complete alignment.” The release also stated enVVeno has been busy speaking with clinical sites that are interested in participating in the TAVVE study.
About the TAVVE Study
The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.
The post enVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous Valve appeared first on MedTech Intelligence.
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