Healthcare Industry News:  Organ Care System 

Devices FDA

 News Release - April 19, 2007

FDA Grants IDE Approval to TransMedics for the Pilot Phase of the PROCEED Clinical Trial for Its Organ Care System(TM) - the First System to Support Beating Heart Transplant

ANDOVER, Mass.--(HSMN NewsFeed)--TransMedics, Inc., an emerging medical technology company developing advanced solutions for better, more organ transplant technologies, announced today it has received IDE approval to initiate the pilot phase of the PROCEED multi-center clinical trial in the U.S. for its Organ Care System(TM). The PROCEED trial will evaluate the safety and performance of the Organ Care System (OCS) for heart transplants in the U.S.

The pilot phase of the PROCEED trial is designed to enroll 20 patients and will take place at five leading U.S. transplant centers, including; University of Pittsburgh Medical Center, UCLA Medical Center, The Cleveland Clinic, The University of Chicago Medical Center and Brigham & Women's Hospital.

The Organ Care System represents a significant advancement in the practice of organ transplant for end-stage organ failure and is the first and only system designed to maintain organs in a warm, functioning, "living" state outside of the body. Using the Organ Care System, hearts are maintained in a beating, functioning state 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.

With organs maintained in a near normal physiologic functioning state, the Organ Care System 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 time dependant injury to the organ, resulting in significant underutilization of the current pool of consented, donated organs.

TransMedics recently completed its PROTECT I trial in Europe. Participating sites included; Clinic for Thoracic & Cardiovascular Medicine, Bad Oeynhausen and the German Heart Institute in Berlin, Germany, as well as Papworth Hospital and Harefield Hospitals, NHS Trusts in Cambridge and Middlesex, United Kingdom, respectively. Results from the PROTECT I European trials will be presented at the International Society of Heart and Lung Transplantation Society Annual Meeting and Scientific Sessions in San Francisco at the end of April.

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

Source: TransMedics

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