TransMedics Earns Second PMA For OCS Lung System

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.

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The US Food and Drug Administration approved a panel-track PMA supplement for TransMedics Inc.’s Organ Care System (OCS) Lung, allowing it to be used for the preservation of donor lungs that would be unacceptable for transplantation with standard cold static preservation.

OCS Lung combines perfusion, ventilation and monitoring systems into a single portable device that can maintain donated lungs in a near-physiologic state, giving transplant physicians time to assess and improve...

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