Research & Development
TransMedics passes US FDA's pre-market approval (PMA) for OCS Lung System for double lung transplantation
13 April 2018 -

Medical technology company TransMedics Inc reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for its Pre-Market Approval Application (PMA) for the Organ Care System (OCS) Lung platform for the standard double lung transplant indication.

The company added that the US FDA's PMA was based on the company's INSPIRE Trial, which is the first and largest controlled clinical organ preservation trial ever in lung transplantation, that was conducted at 21 international academic institutions.

In conjunction, the primary objective of the INSPIRE Trial was to compare the safety and effectiveness of the OCS Lung System to the current cold storage standard of care for the preservation of standard criteria donor lungs. The trial results demonstrated reasonable assurance of safety and effectiveness of the OCS Lung System in standard criteria double lung transplantation, revealed the company.

According to the company, Organ Care System (OCS) is a revolutionary first-in-class technology and multi-organ platform, with the potential to both improve outcomes for transplant patients and increase the number of transplantable organs worldwide. The OCS is the only fully portable technology that maintains donor organs in a near-physiologic state outside of the human body and addresses the current limitations of the cold storage.

To-date, there has been >950 successful human transplants using the OCS System world-wide. The OCS Heart, OCS Lung and OCS Liver systems are CE Marked and are in use at leading transplant centres in Europe, Australia and Canada, concluded the company.



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