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
Queen Mary Hospital, Hong Kong
Queen Mary Hospital Main Block, Pok Fu Lam Rd, Pok Fu Lam, Hong Kong
The Prince Charles Hospital, Brisbane, Australia
627 Rode Rd, Chermside QLD 4032, Australia
Fiona Stanley Hospital, Perth, Australia
11 Robin Warren Dr, Murdoch WA 6150, Australia
St. Vincent Hospital, Sydney, Australia
406 Victoria St, Darlinghurst NSW 2010, Australia
Vienna General Hospital (AKH), Vienna, Austria
Währinger Gürtel 18-20, 1090 Wien, Austria
Toronto General Hospital (UHN), Toronto, Canada
200 Elizabeth St, Toronto, ON M5G 2C4, Canada
Institute of Clinical and Experimental Medicine (IKEM), Prague, Czech Republic
9, Vídeňská 1958, 140 21 Praha 4, Czechia
Rigshospitalet, Copenhagen, Denmark
Blegdamsvej 9, 2100 København, Denmark
CHRU de Lille, Lille, France
2 Avenue Oscar Lambret, 59000 Lille, France
CCML, Paris, France
133 Avenue de la Résistance, 92350 Le Plessis-Robinson, France
Universitatsklinikum Essen, Germany
Hufelandstraße 55, 45147 Essen, Germany
Universitats Herzzentrum, Freiburg-Bad Krozingen, Germany
Südring 15, 79189 Bad Krozingen, Germany
Medizinische Hochsschule Hannover, Germany
Carl-Neuberg-Straße 1, 30625 Hannover, Germany
Ospedali Dei Colli, Naples, Italy
Via Gaetano Quagliariello, 54, 80131 Napoli NA, Italy
Ospedale Niguarda, Milan, Italy
Piazza dell'Ospedale Maggiore, 3, 20162 Milano MI, Italy
Azienda Ospedaliera di Padova, Padova, Italy
Via Nicolò Giustiniani, 2, 35128 Padova PD, Italy
Azienda Sanitaria Universitaria Integrata Di Udine, Udine, Italy
Via Pozzuolo, 330, 33100 Udine UD, Italy
National Research Cardiac Surgery Center, Astana, Kazakhstan
Turan Ave 38, Nur-Sultan 020000, Kazakhstan
King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia
Zahrawi St, Al Maather، Riyadh 12713, Saudi Arabia
Queen Elizabeth Hospital, Birmingham, UK
Mindelsohn Way, Birmingham B15 2TH, UK
Harefield Hospital, London, UK
Hill End Rd, Harefield, Uxbridge UB9 6JH, UK
Wythenshawe Hospital, Manchester, UK
Southmoor Rd, Roundthorn Industrial Estate, Wythenshawe, Manchester M23 9LT, UK
The Freeman Hospital, Newcastle, UK
Freeman Rd, High Heaton, Newcastle upon Tyne NE7 7DN, UK
Royal Papworth Hospital, Cambridge, UK
Papworth Rd, Trumpington, Cambridge CB2 0AY, UK
Golden Jubilee Hospital, Glasgow, Scotland
Agamemnon St, Clydebank G81 4DY, UK
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