Final Results from The Heart EXPAND Pivotal Trial Using the Organ Care System (OCS) Heart Technology Presented at the 2019 Annual Meeting of The International Society for Heart and Lung Transplantation in Orlando
Andover, Massachusetts, April 4th, 2019 – TransMedics, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, announced the final results of the OCS™ Heart EXPAND Trial were presented at the 39th annual meeting of the International Society for Heart and Lung Transplantation in Orlando, Florida by the lead investigator, Dr. Jacob Schroder on behalf of the EXPAND Trial investigators.
Today in the U.S., only 30-35% of donated hearts are used for transplantation due to limitations of cold storage preservation. The OCS Heart EXPAND Trial focused on assessing the impact of using the OCS Heart’s perfusion, optimization and assessment capabilities to potentially improve utilization of donor hearts that are currently limited by cold storage preservation.
Dr. Schroder presented results which demonstrated that using the OCS Heart resulted in successful transplantation of 81% of donor hearts that may not be used routinely with cold storage, with patient survival of 95% at 30 days after transplantation.
“We used donor hearts that would often have been wasted because of the inability to assess their viability using conventional cold storage. The OCS Heart also enabled investigators to travel longer distances to retrieve donor hearts to help more of our patients on the waiting list for a heart transplant,” said Dr. Schroder. “We are encouraged by these potentially transformative results of the OCS Heart EXPAND Trial.”
“These results have the potential to significantly expand the number of viable donor hearts for transplantation to help patients in need,” said Dr. Waleed Hassanein, CEO of TransMedics, Inc. “We are grateful for the dedication and commitment of the OCS Heart EXPAND Trial investigators and, most importantly, we would like to thank the heart transplant patients who participated in the trial.”
About TransMedics, Inc. & The Organ Care System (OCS) Technology
TransMedics is the world’s leader in portable ex-vivo warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation, and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung and liver failure.
TransMedics has developed the Organ Care System (OCS), an innovative 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 replicates near-physiologic conditions for donor organs outside of the human body and addresses the current limitations of cold storage. The OCS Lung is FDA approved and CE Marked, OCS Heart is under review by the FDA and is CE Marked, and OCS Liver is CE Marked. These three products are in commercial or investigational use at leading transplant centers in the U.S., Europe, Australia and Canada.
Tamer Khayal, MD
Chief Commercial Officer