OCS™ Heart
The only device currently under FDA review for utilized and unutilized donor hearts
The Only Heart Device Currently Under FDA Review for Utilized and Unutilized Criteria Organs
The OCS Heart is an investigational device and, therefore, limited by federal law to investigational use in the US.
The OCS Heart is
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
EXPAND 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 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
Locate An OCS Heart Center
The OCS Heart is under FDA review for use with utilized and unutilized donor hearts. OCS Heart is an investigational device and is, therefore, limited by federal law to investigational use in the US. The OCS Heart is CE marked and commercially available in Europe and Australia.
University of Washington Medical Center
9725 3rd Ave NE #400
Seattle, WA 98115
(206) 598-3300
Duke University Hospital
10 Duke Medicine Circle
Durham, NC 27710
(919) 372-3345
Mount Sinai Medical Center
1 Gustave L. Levy Pl New York, NY 10029
(212) 241-6741
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, TN 37232
(615) 322-5000
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.
ONLY
multi-organ platform
SUBSTANTIAL
body of clinical evidence