TransMedics' OCS Lung System Receives FDA Pre-Market Approval

The US Food and Drug Administration announced the approval of TransMedics, Inc.’s pre-market approval (PMA) application for the Organ Care System (OCS) Lung platform for the standard double lung transplant indication that occurred March 22.

The approval is supported by the 316-patient INSPIRE trial — the first and largest controlled clinical organ preservation trial in lung transplantation. The objective was to compare the safety and effectiveness of the system to the current cold storage standard of care for preservation of standard criteria donor lungs.

“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 US,” Waleed Hassanein, MD, chief executive officer, TransMedics, Inc., said in a statement.

Trial results demonstrated reasonable assurance of safety and effectiveness of the OCS Lung System in standard criteria double lung transplantation.

INSPIRE met its primary outcome which included a composite of patient survival rate at 30 days, as well as the rate of absence of International Society for Heart and Lung Transplantation (ISHLT) primary graft dysfunction Grade 3 within 72 hours.

The trial also met 3 of its secondary outcomes of which were the rate of ISHLT primary graft dysfunction Grade 3 alone at 72 hours, rate of ISHLT primary graft dysfunction Grade 2 at 72 hours and patient survival at day 30.

“To our knowledge, this is the first reported clinical, pre-emptive therapy to reduce the incidence of severe primary graft dysfunction Grade 3 in lung transplantation,” study authors stated in The Lancet Respiratory Medicine publication. “This reduction of primary graft dysfunction in the OCS group also translated into clinically meaningful, but not statistically significant, shorter ventilation, intensive care unit and hospital stay times.”

Although there was no short-term survival benefit reported, further research is needed to determine whether the reduced incidence of primary graft dysfunction Grade 3 within 72 hours of a transplant would translate into earlier recovery and improved long-term outcomes.

OCS is a revolutionary, first-in-class technology and multi-organ platform that offers the potential to improve outcomes for transplant patients and increase the number of transplantable organs worldwide and is the only fully portable technology that maintains donor organs in near-physiologic state, addressing current limitations of the cold storage.

To-date there has been more than 950 successful human transplants using the OCS System world-wide.