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enVVeno Medical Seeks FDA Approval for VenoValve in Severe Chronic Venous Insufficiency

• enVVeno Medical has submitted its Premarket Approval (PMA) application to the FDA for VenoValve, a surgical replacement venous valve. • The VenoValve is intended for treating severe deep venous Chronic Venous Insufficiency (CVI), a condition affecting approximately 2.5 million people in the U.S. annually. • The FDA has granted VenoValve breakthrough device designation, which allows for priority review of the application. • enVVeno anticipates a potential FDA decision on the VenoValve PMA in the second half of 2025.

enVVeno Medical Corporation (NASDAQ:NVNO) has announced the submission of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the VenoValve. This device is intended for the treatment of severe deep venous Chronic Venous Insufficiency (CVI). The company anticipates a potential FDA decision in the second half of 2025.

VenoValve: A Novel Approach to CVI Treatment

The VenoValve is a surgical replacement venous valve designed to address the underlying cause of deep venous CVI. This debilitating condition often results from blood clots (deep vein thromboses or DVTs) that damage the valves within the leg veins, leading to backward blood flow and venous hypertension. Symptoms of severe CVI include leg swelling, pain, edema, and recurrent venous ulcers, significantly impacting patients' quality of life.
Robert Berman, enVVeno Medical's Chief Executive Officer, stated, "We are thrilled to get this last step of the PMA review process underway and look forward to further interactions with the FDA."

Unmet Needs in CVI Treatment

Currently, there are limited effective treatments for deep venous CVI, leaving a significant unmet medical need. enVVeno estimates that approximately 2.5 million individuals in the U.S. are potential candidates for the VenoValve each year. The VenoValve aims to restore proper blood flow in the legs, alleviating the symptoms and complications associated with CVI.

Breakthrough Device Designation and Priority Review

The FDA has designated the VenoValve as a breakthrough device, which means it is subject to priority review. This designation is reserved for devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions.

enVVe: A Next-Generation Transcatheter Valve

enVVeno is also developing enVVe, a next-generation, non-surgical transcatheter-based replacement venous valve. The company anticipates that enVVe will be ready for its own pivotal trial by mid-2025. This less invasive approach could expand the treatment options for CVI patients and appeal to a broader range of physicians.

SAVVE Pivotal Trial Data Presentation

Definitive one-year data supporting the VenoValve PMA application was presented at the 51st Annual Vascular and Endovascular, Techniques and Horizons (VEITH) Symposium in New York City on Wednesday, November 20, 2024. Following the presentation, enVVeno hosted a live video conference call with the principal investigators to discuss the pivotal trial data.
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Reference News

[1]
enVVeno Medical Submits the VenoValve PMA Application Seeking FDA Approval
finance.yahoo.com · Nov 19, 2024

enVVeno Medical submitted its VenoValve PMA application to the FDA, with four modules approved; the final module include...

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