enVVeno Receives Not-Approvable Letter from the FDA for the VenoValve

enVVeno Medical (NASDAQ:NVNO) has received a not-approvable letter from the FDA for its VenoValve® PMA application, a surgical replacement venous valve designed to treat severe deep chronic venous insufficiency (CVI). The FDA determined that the clinical improvement data was insufficient to establish a favorable benefit-risk profile.

The FDA cited concerns about the lack of specific hemodynamic measurements correlating with patient improvement and raised safety issues related to the surgical procedure requiring re-hospitalizations. Despite showing improvements in revised Venous Clinical Severity Score (rVCSS), pain scores, and quality of life indicators, the FDA suggested potential study bias.

The company is evaluating options, including potential FDA discussions for resubmission or appeal, while continuing development of enVVe, its non-surgical replacement venous valve alternative.

https://www.stocktitan.net/news/NVNO/en-v-veno-receives-not-approvable-letter-from-the-fda-for-the-veno-0bk1dht7lqm2.html