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 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 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 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
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
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
Stanford University Hospital
300 Pasteur Drive
Stanford, CA 94305
601 East Rollins Street
Orlando, FL 32803
Abbott Northwestern Hospital
800 E 28th Street
Minneapolis, MN 55407
New York Presbyterian/Columbia University Medical Center
622 W 168th Street
New York, NY 10032
UW Health University Hospital
600 Highland Avenue
Madison, WI 53792
St. Vincent Indianapolis Hospital
2001 W 86th Street
Indianapolis, IN 46260
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.
The OCS Lung is an FDA approved device for standard and expanded* criteria 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.
*Expanded criteria is defined as donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.
body of clinical evidence