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TransMedics says trial of Organ Care System successfully perfused heart for transplantation.

TransMedics, Inc., San Francisco, CA, announced results from its European PROTECT 1 clinical trial on its Organ Care System (OCS) in maintaining and transporting donated hearts for transplant surgery had been successful. The company says in the 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.

TransMedics reports the study met the primary endpoints and achieved a 30-day patient and graft survival of 100%. 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 study included the Clinic for Thoracic & Cardiovascular Medicine, Bad Oeynhausen, the Germany Heart Institute in Berlin Germany, the Papworth Hospital in Cambridge, UK and Harefield Hospitals, NHS Trusts in Middlesex, UK.

The company says the patients in the study received hearts within a mean total ischemic time of only 76 minutes. International registry data shows that heart transplant patients who receive a donor heart with 1 hour of ischemic time reduce their risk of dying within a year of transplantation by more than 40% compared to patients who receive a donor organ with 5 hours of ischemic preservation.

TransMedics is presently expanding the number of centers working with the OCS to include hospitals in Italy, Austria and France. Additionally, the company has received FDA approval to initiate clinical trials in the US to evaluate the safety and performance of OCS for heart transplants in the US. The trials will take place in five centers, including the University of Pittsburgh Medical Center, Pittsburgh, PA; UCLA Medical Center in Los Angeles, CA; The Cleveland Clinic Heart and Vascular Institute in Cleveland, OH, The University of Chicago Hospitals and Cardiac Center in Chicago, IL; and Brigham and Women's Hospital in Boston, MA.

Contact: David Kolstad - (978) 552-0927, e-mail:
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Publication:Transplant News
Date:May 1, 2007
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