Healthcare Industry News: PROTECT Trial
News Release - April 26, 2007
TransMedics, Inc. Announces Successful Results for First Ever Beating Heart Transplant Study Using the Organ Care SystemSAN FRANCISCO--(HSMN NewsFeed)--TransMedics, Inc., an emerging medical technology company developing advanced solutions for better, more effective organ transplants, announced today the results from the European PROTECT I trial demonstrating the successful use of the Organ Care System(TM) (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.
About the Organ Care System
The Organ Care System is the first and only system designed to maintain organs in a warm, functioning, "living" state outside of the body during transport from organ donor to recipient. This design optimizes organ health and allows ex-vivo clinical evaluation for the first time ever. The OCS offers the real potential of increasing the availability of donor organs and dramatically reducing the cost of treatment for the large and growing population of end-stage organ failure patients worldwide.
The OCS optimizes the organ's health and allows for continuous clinical evaluation. Physicians can perform visual, functional and metabolic assessment of the organ to reduce the risk of organ rejection and increase the number of organs accepted for transplant. Current cold ischemic preservation and transportation methods - which essentially consist of transporting the organ in an ordinary beverage cooler - create severe time limitations, as well as potential injury to the organ, resulting in significant underutilization of the current pool of consented, donated organs.
The Growing Need for New Transplant Technologies
The number of people requiring a life-saving transplant continues to rise faster than the number of available donors. Of the 96,000 people in the U.S. currently waiting for a donor organ, only a third will receive a transplant, while nearly 7,000 will die each year while waiting for an organ. This means approximately 19 transplant candidates die each day while waiting to receive a donor organ.
About TransMedics, Inc.
TransMedics is a privately held medical technology company dedicated to extending the life saving benefits of organ transplantation to patients suffering from end-stage organ failure. Headquartered in Andover, Massachusetts, the company was founded in 1998 to address the unmet need for better, more organ transplant technologies. The Organ Care System(TM) is designed to help increase the number of organs utilized for transplantation as well as improve the health of organs being transplanted, improving outcomes and reducing recovery time, hospital stays and reliance on ongoing medical therapies. The system has obtained CE Marking in Europe and has received an Investigational Device Exemption from the FDA to begin clinical studies in the United States. For more information, please visit www.TransMedics.com.
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