TransMedics gets US trial OK for organ care system
This article was originally published in Clinica
Edging closer to a worldwide $1bn market, TransMedics has received IDE approval from the US FDA to begin the pilot phase of clinical trials for its Organ Care system (OCS), which preserves donor organs in a "living" state outside of the body. The PROCEED trial will evaluate the safety and performance of the OCS in 20 patients, from five centres across the US: the University of Pittsburgh Medical Center, UCLA Medical Center, The Cleveland Clinic, The University of Chicago Medical Center and Brigham & Women's Hospital.
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