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VenoValve

Severe Symptomatic Deep Venous Chronic Venous Insufficiency (CVI) due to Proximal Deep Venous Reflux

PivotalPMA Under ReviewNCT03491649

Key Facts

Indication
Severe Symptomatic Deep Venous Chronic Venous Insufficiency (CVI) due to Proximal Deep Venous Reflux
Phase
Pivotal
Status
PMA Under Review
Company

About enVVeno Medical

enVVeno Medical is a public medical device company with a mission to develop and commercialize innovative, minimally invasive treatments for chronic venous insufficiency (CVI). Its core achievement is the VenoValve®, a novel bioprosthetic valve that has successfully completed a pivotal U.S. trial (SAVVE) and is now under Pre-Market Approval (PMA) review by the FDA. The company's strategy is to secure regulatory approval and establish the VenoValve as the new standard of care for deep venous CVI, leveraging its first-mover advantage in a large, underserved market.

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