The only FDA approved technology for extracorporeal perfusion and preservation of donor hearts in the U.S.
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.
OCS Heart EXPAND Clinical Trial Results
U.S. pivotal trial to evaluate the Organ Care System for use with unutilized donor hearts that may not meet current standard acceptance criteria for transplantation.
270+ DCD Heart Transplants
OCS™ Heart is the only system used in DCD heart transplantation worldwide
With 75 patients enrolled, the following types of expanded criteria donor hearts were 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)
Primary Effectiveness Endpoints
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 transplant center.
Absence of severe primary heart graft dysfunction (PGD) in the first 24 hours post-transplantation
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Locate an OCS Heart Center Near You
The OCS Heart is FDA approved. The OCS Heart is CE marked and commercially available in Europe, Australia, Canada, Middle East and Asia.
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
Houston Methodist Hospital
6565 Fannin St
Houston, TX 77030
Henry Ford Hospital
2799 W Grand Blvd
Detroit, MI 48202
UT Southwestern Medical Center
5323 Harry Hines Blvd
Dallas, TX 75390
University of Virginia HSC
1189-1221 Lee St
Charlottesville, VA 22903
1250 East Marshall Street
Richmond, VA 23298
Emory University Hospital
1365 Clifton Road Northeast, Building B
Atlanta, GA 30322
Johns Hopkins Hospital
1800 Orleans St
Baltimore, MD 21287
University of Minnesota Medical Center
909 Fulton St. SE
Minneapolis, MN 55455
University of Washington Medical Center
9725 3rd Ave NE #400
Seattle, WA 98115
University of CA San Francisco Medical Center
505 Parnassus Ave
San Francisco, CA 94143
Ohio State University Medical Center
410 W 10th Ave
Columbus, OH 43210
Scripps Green Hospital
10666 N. Torrey Pines Rd.
La Jolla, CA 92037
4502 Medical Drive
San Antonio, TX
Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Methodist University Hospital
1265 Union Avenue
Memphis, TN 38104
Montefiore Medical Center
111 East 210 Street
Bronx, NY 10467
Mount Sinai Medical Center
1 Gustave Levy Place
New York, NY 10029
The Nebraska Medical Center
42nd and Emile
Omaha, NE 68198
University of California San Diego Medical Center
9300 Campus Point Drive
San Diego, CA 92037
The OCS Lung, OCS Heart and OCS Liver are all CE marked devices. The OCS Lung is an FDA approved device for standard and expanded1 criteria donor lungs. The OCS Heart is an FDA approved device for expanded2 criteria donor hearts. The OCS Liver is an FDA approved device for DCD3 and DBD donor Livers.
1. Expanded criteria lungs is defined as donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.
2. Expanded criteria hearts is defined as donor hearts that are deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
3. DCD livers < 55 years old with < 30 mins warm ischemia time and macrosteatosis < 15%.
Only multi-organ platform used with donor lungs, hearts and livers
Largest user base at 70 leading US and global transplant centers
Largest body of literature and clinical evidence in warm perfusion
Most extensive training program including 24/7 clinical support