enVVeno Medical Corporation announced that it has received a not-approvable letter from the U.S. Food & Drug Administration (FDA) in response to its Premarket Approval (PMA) application for VenoValve. The letter indicates that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form.
This regulatory setback means the VenoValve will not be approved for marketing and sale in the U.S. at this time, significantly impacting the company's immediate commercialization plans. The VenoValve holds Breakthrough Device designation, but this did not prevent the not-approvable decision.
The company will need to address the FDA's concerns, which may involve providing additional data or conducting further studies, before resubmitting its application. This development introduces delays and potential additional costs for enVVeno Medical as it seeks to bring its innovative device to market.
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