enVVeno Medical presents preliminary device related MAE safety data from SAVVE

enVVeno Medical announced that preliminary device related Material Adverse Event 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. MAEs for the SAVVE study are defined as all-cause mortality, pulmonary embolisms, ipsilateral deep vein thromboses, bleeding, and deep wound infections, occurring within thirty days of enrollment in the study. The report on MAEs presented at the conference indicates no deaths, no pulmonary embolisms, and six deep vein thromboses, from the fully enrolled cohort of 75 patients. MAEs for the SAVVE study are adjudicated by an independent Clinical Events Committee and the overall safety of SAVVE is monitored by an independent Data Safety Monitoring Board. 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 of the DVT MAEs have been adjudicated by the CEC as being device related and mild in severity. The other three DVT MAEs have not yet been adjudicated by the CEC but are expected to yield similar results. While certain types of MAEs such as deaths, PEs, and DVTs are of prime concern because they are more likely to permanently impair the long-term health of the patient, other types of MAEs such as procedure related bleeding and wound infections are acute, episodic events, that are less likely to have any permanent negative impact and are therefore of less significance. In addition, safety events such as deaths, PEs and DVTs are more likely to be caused by the device, while bleeds, and wound infections, are more likely to have a causal relationship to the procedure. As to the clinical impact of the DVT MAEs, three of the patients have shown significant clinical improvement when comparing most recent rVCSS values to baseline scoring, two of the patients have not yet reached the ninety day visit where clinical change is evaluated, and one patient voluntary withdrew from the study after thirty days. The preliminary topline MAE related safety data from SAVVE also includes a higher-than-expected procedure related bleeding rate for a small sub-group of contiguous patients, all of which occurred within the first two weeks after surgery, were deemed to be moderate in severity by the CEC, and resulted from anticoagulation medication, as well as an expected rate of wound infections at the site of the skin incisions. All safety and associated clinical data for these patients is unaudited, and subject to change. The CEC will continue to adjudicate safety events and the DSMB will continue to monitor the overall safety of SAVVE throughout the duration of the study. All safety events will also be evaluated by the U.S. Food and Drug Administration, as part of the Company’s application seeking pre-market approval for the VenoValve. The Company plans to present initial topline efficacy data from the SAVVE study in Q2 of 2024 and expects to be ready to file the PMA application for the VenoValve with the FDA in Q4 of 2024.