TransMedics locks in 2nd FDA approval in a month with nod for donor liver preservation system

After several years with only one of its three donor organ preservation systems approved by the FDA, TransMedics has secured premarket approvals for the other two iterations of the Organ Care System, or OCS, in rapid succession.

Mere weeks after receiving the agency’s nod for its heart-preserving cart, the version of the “miniature intensive care unit” designed to extend and improve the function of donor livers has garnered an FDA green light of its own. These back-to-back approvals join the one bestowed upon OCS Lung in 2018.

Like its predecessors, OCS Liver is a portable system that uses warm, oxygenated blood perfusion technology to store and transport donor organs in a human-like state, with their function and viability tracked throughout the entire process using monitoring tools embedded in the wheeled cart. The system keeps hearts beating, lungs breathing and livers producing bile and helps extend the life of organs that might have otherwise been excluded from the donor list.

With the liver system’s approval, TransMedics is aiming to make all three OCS carts commercially available by the fourth quarter of this year, CEO Waleed Hassanein, M.D., said in a statement.

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The FDA’s approval allows OCS Liver to preserve organs collected from donors after brain or circulatory death to be transplanted in patients with end-stage liver failure. It follows an advisory committee meeting convened by the agency in July, during which a panel of 14 experts voted unanimously in favor of OCS Liver’s efficacy and safety.

The decisions from the advisory committee and, subsequently, the FDA were based on a clinical trial of the system conducted across several years that compared OCS Liver’s ability to preserve donor livers for transplant to that of cold storage, the current go-to preservation method.

In the Protect study, OCS-preserved livers resulted in fewer post-transplant complications than those stored on ice, with 18% of the OCS organs leading to early allograft dysfunction, compared to more than 30% in the cold storage group. Those trends held in the long term, too, with only 2.6% of those preserved with TransMedics’ system experiencing ischemic biliary complications through the first year after transplant, compared to nearly 10% of the ice-preserved livers.

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Additionally, TransMedics’ monitoring technology helped keep more donor livers viable for transplant. According to the trial’s results, more than half of livers that came from donors after cardiac death were able to be used after being transported in the warm perfusion system, while only 25% were utilized after being kept on ice.

“I am convinced that broad availability of warm extracorporeal donor liver perfusion will be the most important advance for the field of liver transplantation in decades,” said James Markmann, M.D., transplantation surgery chief at Massachusetts General Hospital, and principal investigator of the company's clinical trial. “The OCS Liver has the potential to save many lives by making liver transplants safer and by expanding the pool of available liver allografts.”