OCS™ Lung
The only FDA-approved device for utilized lung transplant. Currently under FDA review for unutilized lung transplant
The Only FDA-approved, Portable, Lung Perfusion System For Utilized Donor Lungs
The OCS Lung is a portable perfusion, ventilation, and monitoring system that maintains the organ at a near-physiologic state – allowing physicians to assess and improve the condition of lungs between the donor and recipient sites.
The Benefits of OCS Lung
INSPIRE TRIAL
The OCS Lung is FDA approved for use with utilized donor lungs
Improved post-transplant outcomes compared to cold storage
~50% reduction of primary graft dysfunction (PGD) grade 3*
Significantly expanded organ retrieval range while limiting ischemic time
Reduction of PGD3 with OCS
*PGD3 is the most common and severe clinical complication of lung transplantation and is a predictor of short and long-term morbidity and mortality post transplantation.
TransMedics OCS Lung significantly reduced PGD3 vs control group in the INSPIRE Trial.
Significant Reduction of PGD3 within 72 Hours
EXPAND TRIAL
The OCS Lung is currently under FDA review for use with unutilized donor lungs
International pivotal trial to evaluate the Organ Care System for use with unutilized donor lungs that may not meet current standard acceptance criteria for transplantation.
- 79 patients were enrolled worldwide
- Types of donors used
– Older donors ≥55 years – 39%
– DCD donors – 33%
– Ischemic time >6 hours – 32%
– PaO2/FiO2 ratio ≤300 mmHg –25%
– 20 patients had 2+ indications
- UNOS data showed donor lungs used for the OCS Lung EXPAND Trial had been declined for transplantation on average 35 times by other transplant centers before reaching an OCS Trial Center
- Primary effectiveness endpoints:
– Patient survival at 30 days post transplant
– Absence of Primary Graft Dysfunction (PGD) grade 3 during the first 72 hours post transplant
Locate an OCS Lung Center
The OCS Lung is FDA approved for use with utilized donor lungs. It is currently under FDA review for use with unutilized donor lungs. The OCS Lung is CE marked and commercially available in Europe and Australia.
Massachusetts General Hospital
Main Campus
55 Fruit Street
Boston, MA 02114
(617) 726-2000
Houston Methodist Hospital
6565 Fannin St
Houston, TX 77030
Johns Hopkins Hospital
1800 Orleans St
Baltimore, MD 21287
(410) 955-5000
University of Minnesota Medical Center
909 Fulton St. SE
Minneapolis, MN 55455
(612) 273-8383
University of CA San Francisco Med Center
505 Parnassus Ave
San Francisco, CA 94143
(415) 353-1664
Duke University Medical Center
10 Duke Medicine Circle
Durham, NC 27710
(919) 372-3345
Temple University Hospital
3401 N Broad St
Philadelphia, PA 19140
(215) 707-2000
St Luke's Baylor
6720 Bertner Ave
Houston, TX 77030
(832) 355-1000
St. Joseph's (Dignity Health)
350 W Thomas Rd
Phoenix, AZ 85013
(602) 406-3000
University of Virginia (UVA)
1215 Lee St
Charlottesville, VA 22903
(434) 924-0000
UCLA Medical Center
757 Westwood Plaza
Los Angeles, CA 90095
(310) 825-9111
MCW/Froedtert
9200 W Wisconsin Ave
Milwaukee, WI 53226
(414) 805-3000
Stanford Medical Center
300 Pasteur Drive
Stanford, CA 94305
(650) 498-7878
The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.
The OCS Lung is an FDA-approved device for utilized 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.
ONLY
multi-organ platform
SUBSTANTIAL
body of clinical evidence