enVVeno Receives Unfavorable FDA Appeal Decision for VenoValve Approval

EnVVeno Medical Corporation has received an unfavorable decision from the FDA in response to its supervisory appeal for VenoValve, a surgical replacement venous valve for treating severe deep chronic venous insufficiency. The FDA upheld the review staff decision, stating that VenoValve does not meet the standard of reasonable assurance of safety and effectiveness. The decision is disappointing for the company, which was hoping for approval for its product.