TransMedics - Model OCS Heart - Organ Care System
The Only Heart Device Currently Under FDA Review for Utilized and Unutilized Donor Organs. The OCS Heart is a portable, warm perfusion, and monitoring system designed to keep a donor heart at a human-like, metabolically active state. By monitoring key parameters of the functioning heart, physicians may use their medical judgement to assess a potentially suitable heart’s condition and viability. The OCS Heart is an investigational device and, therefore, limited by federal law to investigational use in the US.
OCS Heart Clinical Trial
US pivotal trial to evaluate the Organ Care System for use with unutilized donor hearts that may not meet current standard acceptance criteria for transplantation.
- 75 patients were enrolled
- Types of expanded criteria donor hearts used
- 37% – Expected ischemic time >4 hours
- 31% – 20 or more mins of down time
- 28% – LVEF of 40-50%
- 13% – Older donors >55 years
- 8% – Coronary artery disease
- (31 patients had 2 or more indications)
- UNOS data showed donor hearts used for the OCS Heart EXPAND Trial had been declined for transplantation on average 66 times by other transplant centers before reaching an OCS Trial Center
- Primary effectiveness endpoints:
- Patient survival at day-30 post transplant
- Absence of severe primary heart graft dysfunction (PGD) in the first 24 hours post-transplantation
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