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enVVeno Medical Presents Positive Preliminary Device Related Material Adverse Event (MAE) Data from the VenoValve Pivotal Trial at the 50th Annual VEITH Symposium
No Deaths or Pulmonary Embolisms Occurring During the 30 Day MAE PeriodExpected Overall Device-Related Material Adverse Event Rate of 8% for the Fully
About this update from Envveno Medical Corporation
[{"type":"text","content":"No Deaths or Pulmonary Embolisms Occurring During the 30 Day MAE PeriodExpected Overall Device-Related Material Adverse Event Rate of 8% for the Fully Enrolled 75 Patient StudySix (6) DVT Related MAEsIRVINE, CA / ACCESSWIRE / November 16, 2023 / enVVeno Medical Corporation (Nasdaq:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today announced that positive preliminary device related Material Adverse Event (MAE) safety data from the SAVVE U.S. pivotal trial for the VenoValve is being presented today at the 50th Annual VEITH symposium in New York. The preliminary device related MAE rate for the fully enrolled 75 subject study is reported to be eight percent (8%). MAEs for the SAVVE study are defined as all-cause mortality, pulmonary embolisms (PEs), ipsilateral deep vein thromboses (DVTs), bleeding, and deep wound infections, occurring within thirty (30) days of enrollment in the study. The report on MAEs presented at the conference indicates no deaths, no pulmonary embolisms, and six (6) deep vein thromboses (DVTs), from the fully enrolled cohort of 75 patients.\"We are very encouraged by the safety data from our SAVVE pivotal study. Importantly, there were no deaths or pulmonary embolisms and a comparatively low DVT rate during the initial thirty (30) day safety monitoring period for this otherwise high-risk group of patients,\" commented Robert Berman, CEO of enVVeno Medical. \"Patients such as those enrolled in the SAVVE study who have had one or more DVTs and that develop Chronic Venous Insufficiency are known to have DVT recurrence rates as high as 18% at one year. With recurrent DVTs occurring immediately or soon after valve implantation being the primary reason why other attempts at replacement venous valves have failed over the past several decades, we are happy to pass this important thirty (30) day safety milestone.\"MAEs for the SAVVE study are adjudicated by an independent Clinical Events Committee (CEC) and the overall safety of SAVVE is monitored by an independent Data Safety Monitoring Board (DSMB). MAEs are adjudicated by the CEC as being severe, moderate, or mild in severity and as having a causal relationship to either the device or the procedure. Three (3) of the DVT MAEs have been adjudicated by the CEC as being device related and mild in se...