enVVeno Medical reports positive preliminary safety data from VenoValve pivotal trial; 8% MAE rate, no deaths or PEs

enVVeno Medical Corp

Preliminary device-related MAE rate 8% for fully enrolled 75-patient SAVVE trial; no deaths or pulmonary embolisms.
Six DVTs occurred; three adjudicated as device-related mild, three pending, expected similar results.
Higher-than-expected procedure-related bleeding in contiguous sub-group, all moderate, attributed to anticoagulation.
Company expects to present topline efficacy data in Q2 2024 and file PMA application in Q4 2024.
enVVeno also developing enVVe transcatheter valve; pivotal trial expected to begin Q4 2024.

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