The approval was based on results of the Inspire study, which is a controlled clinical organ preservation trial carried out at 21 international academic institutions.
The trial compared the safety and effectiveness of the OCS lung system against current cold storage standard of care for the preservation of standard criteria donor lungs.
According to the company, the study results showed reasonable assurance of safety and effectiveness of the OCS lung system in standard criteria double lung transplantation.
Inspire trial US principal investigator Abbas Ardehali said: “This PMA approval is the first crucial step forward towards dramatically improving clinical outcomes and expanding the number of life-saving organ transplant procedures in the U.S. and worldwide.”
Based on the firm’s warm blood perfusion technology, the OCS system features advanced technologies that simulate the conditions of the human body and allow the organ to function as it normally does.
The system incorporates a compact wireless monitor, an organ specific perfusion module, and proprietary solutions for organ maintenance.
OCS is a multi-organ platform that can improve outcomes for transplant patients, and is claimed to be the only fully portable technology that preserves donor organs in a near-physiologic state outside of the human body and deals with the current limitations of the cold storage.
TransMedics secured CE mark approval for OCS Heart, OCS Lung, and OCS Liver systems, which are presently using at transplant centers in Europe, Australia and Canada.
TransMedics CEO Waleed Hassanein said: "This is a major milestone for TransMedics and the field of thoracic transplantation. We are honored and humbled that with this PMA approval, the OCS Lung System is now the only approved medical technology for ex-vivo perfusion and assessment for standard criteria lung transplants in the U.S.”
Image: The OCS lung system. Photo: courtesy of PRNewswire / TransMedics, Inc.
