enVVeno Presents Preliminary Safety Data From SAVVE Pivotal Trial

November 16, 2023—enVVeno Medical Corporation announced positive preliminary device-related material adverse event (MAE) safety data from SAVVE, the United States pivotal trial for the company’s VenoValve, which is intended to restore proper directional blood flow for patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The trial completed enrollment in the SAVVE trial on October 6, 2023.

The company stated there was an 8% preliminary device-related MAE rate for the fully enrolled 75-patient study. The data were presented at the 50th annual VEITHsymposium held November 14-18 in New York, New York.

According to enVVeno, MAEs for the SAVVE study are defined as all-cause mortality, pulmonary embolism (PE), ipsilateral deep vein thrombosis (DVT), bleeding, and deep wound infection, occurring within 30 days of enrollment. There were no deaths, no PEs, and six DVTs.

An independent clinical events committee (CEC) adjudicated MAEs for the SAVVE study. The overall safety of SAVVE is monitored by an independent data safety monitoring board (DSMB). The CEC adjudicates MAEs as severe, moderate, or mild and as device- or procedure-related events.

Three DVTs were adjudicated as mild, device-related MAEs. The other three DVTs have not yet been adjudicated but are expected to yield similar results.

Regarding clinical impact of the DVTs, three patients have shown significant clinical improvement when comparing the most recent revised Venous Clinical Severity Score values to baseline scoring, two patients have not yet reached the 90-day visit where clinical change is evaluated, and one patient voluntarily withdrew from the study after 30 days.

The preliminary topline MAE-related safety data from SAVVE also included a higher-than-expected procedure-related bleeding rate for a small subgroup of contiguous patients, all occurring within the first 2 weeks after surgery. These were deemed moderate in severity by the CEC and resulted from anticoagulation medication. There was also 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, noted enVVeno.

The CEC will continue to adjudicate safety events, and the DSMB will continue to monitor the overall safety of SAVVE throughout the study. All safety events will also be evaluated by the FDA, as part of the company’s application for premarket approval (PMA) for the VenoValve.

EnVVeno advised that it plans to present initial topline efficacy data from the SAVVE study in Q2 2024 and expects to be ready to file the PMA application for the VenoValve with the FDA in Q4 2024.