FDA Reviewers Raise Concerns About Value Of TransMedic’s OCS Liver System Trial Data
As experts convene to discuss whether to recommend approval of the device, agency reviewers are concerned about what the primary endpoint and organ selection criteria used in trials mean for safety and efficacy.
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A panel of medical experts recommended that the US Food and Drug Administration grant premarket approval to a system designed to preserve and monitor livers destined for transplant recipients.
The US FDA panel will look at a PMA for the TransMedics OCS Liver System, which helps keep donor livers stable and healthy as they await transplant.
FDA approved a PMA supplement to allow TransMedics' Organ Care System (OCS) to be used for the preservation and ex-vivo assessment of lungs that would not be acceptable for transplant if they had been preserved with a standard cold static system.