enVVeno Medical Corporation announced the submission of its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. This marks a critical regulatory milestone for the company's lead product, designed to treat severe Chronic Venous Insufficiency (CVI).
Four out of five modules that comprise the VenoValve Premarket Approval (PMA) application had already been submitted, reviewed, and approved by the FDA prior to this final submission. The VenoValve holds Breakthrough Device designation, which may expedite its review process.
The definitive one-year data supporting this PMA application was scheduled to be presented at the 51st Annual VEITH Symposium later in November, providing further clinical evidence for the device's efficacy and safety.
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