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 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 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

(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

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

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

SUBSTANTIAL
body of clinical evidence

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