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 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
OCS™ Heart is the only system used in DCD heart transplantation worldwide
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 expanded criteria donor hearts used37% – 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
Declined Hearts
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.
The OCS Heart is an investigational device and, therefore, limited by federal law to investigational use in the US.
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
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, TN 37232
(615) 322-5000
Stanford University Hospital
300 Pasteur Drive
Stanford, CA 94305
(650) 723-5468
Advent Health
601 East Rollins Street
Orlando, FL 32803
(407) 303-6611
Abbott Northwestern Hospital
800 E 28th Street
Minneapolis, MN 55407
(612) 863-4000
New York Presbyterian/Columbia University Medical Center
622 W 168th Street
New York, NY 10032
(212) 305-2500
UW Health University Hospital
600 Highland Avenue
Madison, WI 53792
(608) 262-5420
St. Vincent Indianapolis Hospital
2001 W 86th Street
Indianapolis, IN 46260
(317) 338-2345
Massachusetts General Hospital
55 Fruit Street
Boston, MA 02114
(617) 726-2000
Cedars-Sinai Medical Center
8900 Beverly Blvd.
Los Angeles, CA 90048
(310) 423-2641
Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
(800) 505-7769
Yale New Haven Hospital
20 York Street
New Haven, CT 06510
203-688-4242
Columbia University Medical Center
177 Fort Washington Ave.
New York, NY 10032
(800) 227-2762
The Ohio State University Medical Center
410 W. 10th Ave.
Columbus, Ohio 43210
(614) 293-8000
St. Vincent Indianapolis Heart Center
2001 West 86th St.
Indianapolis, IN 46260
(317) 338-2345
Emory Transplant Center
1365 Clifton Road Northeast, Building B
Atlanta, GA 30322
(855) 366-7989
Mayo Clinic
4500 San Pablo Rd S
Jacksonville, FL 32224
(904) 956-3309
Medical College of Wisconsin
9200 W Wisconsin Ave.
Milwaukee, WI 53226
(414) 805-3666
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.
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