The only device currently under FDA review for utilized and unutilized donor hearts
Often referred to as a “Heart-in-a-Box”, the OCS Heart™ is a revolutionary system that preserves donor organs.
The OCS acts as a miniature intensive care unit that keeps organs alive and healthy by preserving them in a natural state that mimics the human body
so that organs can remain viable for transplant along the way to recipients.
OCS Heart Clinical Evidence
PROCEED II TRIAL
Randomized study for preservation of utilized donor hearts.
• 128 patients were enrolled worldwide
• Primary effectiveness endpoint
– Patient survival at 30 days post transplant
OUTSIDE THE US
OCS Heart has been used to successfully transplant over 100 hearts from circulatory death donors
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 donors used
– Ischemic time >4 hours – 37%
– 20+ mins of down time – 28%
– EF of 40-50% – 23%
– LVH 13-16 mm – 23%
– Older donors >45 years – 13%
– Coronary artery disease – 7%
– 25 patients had 2+ 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
OUTSIDE THE US
OCS heart has been used to successfully transplant over 100 hearts from circulatory death donors
The OCS Heart is an investigational device and, therefore, limited by federal law to investigational use in the US.
OCS Heart Patient Stories
Hear from a patient who has benefited from the TransMedics OCS and discover if this may be a viable option for you or someone you know.
A heart on ice is a question mark. With an OCS heart, there is no question, it’s a viable heart. It’s ready to be implanted in the recipient.
-Paul, OCS Heart patient
Locate an OCS Heart Center near you
The OCS heart is under FDA review for use with utilized donor hearts. It is currently in clinical trials for use with unutilized donor hearts. OCS heart is an investigational device and is, therefore, limited by federal law to investigational use in the US. It is available in Europe and Australia.
University of Washington Medical Center
9725 3rd Ave NE #400
Seattle, WA 98115
Duke University Hospital
10 Duke Medicine Circle
Durham, NC 27710
Mount Sinai Medical Center
1 Gustave L. Levy Pl New York, NY 10029
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, TN 37232
The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.
The OCS Lung is an FDA-approved device for utilized donor lungs. The OCS Heart and OCS Liver devices are investigational devices and, therefore, are limited by federal law to investigational use in the US.