enVVeno Medical Corporation announced the successful initiation of its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The first wave of implants for the long-term subjects was successfully completed, marking a key step in the device's development.
The final wave for the shorter-term subjects is scheduled for December, indicating a structured progression through the study phases. This GLP study is a prerequisite for enVVeno to seek Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin the enVVe U.S. pivotal study.
The company expects to be in a position to file for IDE approval for the enVVe pivotal trial mid-next year, positioning enVVe as a potential non-surgical option to complement the VenoValve in addressing deep venous CVI.
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