TransMedics receives PMA approval from FDA for OCS Lung system
TransMedics announced that it has received an FDA PMA approval for expanded clinical indications of the Organ Care System, or OCS, Lung. This approval will enable the OCS Lung System to be used for the preservation and ex-vivo assessment of both standard criteria donor lungs as well as the larger pool of donor lungs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation. This approval will also enable the OCS Lung System to be used with both donors after brain death, or DBD, and donors after circulatory death, or DCD. Prior to this latest FDA approval, the OCS Lung System was approved for standard criteria lungs from DBD donors only. Based on this FDA PMA approval, TransMedics will expand its post-market thoracic organ perfusion registry to collect long-term post-market data from recipients of all OCS Lung preserved standard criteria and initially deemed unacceptable donor lungs.