TransMedics said today that it won pre-market approval from the FDA for its OCS Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation.
The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the 316-patient Inspire trial, the results from which were published this week in The Lancet Respiratory Medicine, comparing OCS lung with the standard of care – cold flush and storage.
Inspire met its primary outcome – a composite of patient survival rate at 30 days and the rate of absence of International Society for Heart & Lung Transplantation primary graft dysfunction Grade 3 within 72 hours – and its three secondary outcomes of rate of ISHLT) PGD Grade 3 alone at 72 hours, rate of ISHLT PGD Grade 2 or 3 at 72 hours and patient survival at 30 days. The study’s authors also found other benefits to using OCS Lung, according to a TransMedics press release [The Lancet Respiratory Medicine site was down as of this writing].
“The OCS Lung device significantly reduced primary graft dysfunction Grade 3 within the initial 72 hours after lung transplantation. To our knowledge, this is the first reported clinical, pre-emptive therapy to reduce the incidence of severe PGD3 in lung transplantation,” the authors wrote. “This reduction of PGD3 in the OCS group also translated into clinically meaningful, but not statistically significant, shorter ventilation, intensive care unit, and hospital stay times.”
TransMedics CEO Dr. Waleed Hassanein called the FDA approval a “major milestone” for his company, which raised nearly $64 million in a 2016 funding round.
“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.,” Hassanein said in prepared remarks. ”
Like OCS Lung, other TransMedics systems are already approved in the European Union, Australia and Canada for heart and lung transplantation, used in more than 950 transplantations. Hassanein said the company is working to complete ongoing FDA trials for those products, calling the OCS Lung approval “the first of many PMA approvals that TransMedics has in the pipeline to address the needs of patients on the waiting list for lung, heart and liver transplants.”
“The OCS platform is a paradigm-shifting technology developed to address the current clinical limitations in the transplant field. 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,” added Inspire principal U.S. investigator Dr. Abbas Ardehali of the UCLA Medical Center.