Successful Results for First Ever Beating Heart Transplant Study Using the Organ Care System

SAN FRANCISCO - TransMedics, Inc., an emerging medical technology company developing advanced solutions for more effective organ transplants, has announced the results from the European PROTECT I trial demonstrating the successful use of the Organ Care System™ (OCS) in maintaining and transporting donated hearts for transplant surgery. These data were presented at the International Society for Heart and Lung Transplantation’s (ISHLT) 27th Annual Meeting & Scientific Session in San Francisco.

The PROTECT trial is the PROspective multi-center European Trial to Evaluate the safety and performance of the Organ Care System for Heart Transplants. In this non-randomized, multi-center European study, 20 consented patients received donated hearts that were maintained by the OCS in a perfused and physiologic beating state for a mean time of 3.7 hours. The study met the primary endpoints, and achieved 30-day patient and graft survival of 100 percent. Additionally, the OCS resulted in rapid time to recovery for patients as evidenced by the median length of time patients spent on a ventilator and in the ICU, which were 10.7 hours and 24.3 hours, respectively. The trial sites participating in the PROTECT I study included the Clinic for Thoracic & Cardiovascular Medicine, Bad Oeynhausen, the German Heart Institute in Berlin, Germany, Papworth Hospital in Cambridge, UK and Harefield Hospitals, NHS Trusts in Middlesex, UK.

“These data show the Organ Care System is safe in maintaining human hearts for transplant in near physiologic conditions, reducing ischemic injury, to improve patient outcomes" said Dr. Gero Tenderich from the Thoracic and Cardiovascular Surgery, Heart Center North Rhine-Westphalia, Bad Oeynhausen, Germany. “The OCS represents a significant advancement in organ transplant surgery over current standards of care.”

Patients in the study received hearts within a mean total ischemic time of only 76 minutes. According to previous studies, reducing ischemic time significantly improves patient outcomes. International registry data show that heart transplant patients who receive a donor heart with 1 hour of ischemic time reduce their risk of dying within a year after transplantation by more than 40 percent compared to patients who receive a donor organ with 5 hours of ischemic preservation. Limiting ischemic injury experienced by donor organs may not only improve patient outcomes but also may substantially increase the number of viable hearts available to transplant patients.

“Despite the dramatic medical advances in the science of organ transplantation, one important area that has limited the success and availability of this procedure is the way in which organs are evaluated, maintained and transported between the donor and recipient,” said Mr. Steven Tsui, Director of Transplantation, Papworth Hospital, Cambridge, UK. “The PROTECT trial demonstrates that the Organ Care System may become a valuable new tool allowing more in-depth assessment of donor organs, to make heart transplantation an even more successful treatment.”

TransMedics is presently expanding the number of centers working with the Organ Care System to include hospitals in Italy, Austria and France. Additionally, TransMedics has received FDA approval to initiate the PROCEED clinical trials in the U.S. to evaluate the safety and performance of the OCS for heart transplants. The PROCEED trials will take place at five centers, including University of Pittsburgh Medical Center in Pittsburgh, UCLA Medical Center in Los Angeles, The Cleveland Clinic Heart and Vascular Institute in Cleveland, The University of Chicago Hospitals Cardiac Center in Chicago and Brigham & Women’s Hospital in Boston.