enVVeno Medical has announced positive topline efficacy data from its SAVVE clinical trial examining its VenoValve, demonstrating that 94% of patients using the valve showed clinical improvement. 

The VenoValve is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous chronic venous insufficiency (CVI). It is designed to act as a one-way valve, to help assist in propelling blood up the leg and back to the heart and lungs. 

CVI is a condition where the valves in the deep veins of the legs fail to function properly, leading to impaired blood flow back to the heart and resulting in symptoms such as swelling, pain, and skin changes in the affected area. 

Data presented at the 2024 Charing Cross International Symposium in London, UK, showed that 94% of patients using the VenoValve showed clinical improvement, with 72% experiencing a meaningful benefit, based on a weighted average follow-up of 11.04 and 11.64 months respectively. This was measured using the revised venous clinical severity score (rVCSS), using symptoms and signs such as pain, swelling, and skin changes to determine the severity of the condition. 

The US Food and Drug Administration (FDA) has requested the company to gather at least one year of data on all 75 patients in the SAVVE trial before submitting its premarket approval (PMA) application for FDA approval. The company said in its statement that this is expected to be completed by September 2024. 

In the announcement accompanying the data, enVVeno Medical’s CEO Robert Berman said: “It is so exciting to be achieving what was previously thought to be impossible, and to be continually raising the bar for the potential of the VenoValve. We are hopeful and determined to bring relief with the VenoValve to the millions of patients suffering from severe deep venous CVI, who have no effective treatment options.” 

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At the same time, enVVeno also has another transcatheter-based replacement venous valve in its portfolio known as enVVe. In October 2023, the company revealed its plan to help lower the development cycle of the valve by roughly six months. Currently being investigated in clinical trials, enVVeno plans to be ready to seek investigational device exemption (IDE) approval for the pivotal trial at the end of 2024.