Regulatory & Patents
Regulatory
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, are therefore, 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.
Patents
The following is a list of the TransMedics™ Organ Care System™ (OCS™) patents.
Organ Care System (OCS) Lung
- U.S. Pat. No. 6,100,082
- U.S. Pat. No. 6,046,046
- U.S. Pat. No. 8,585,380
- U.S. Pat. No. 9,055,740
- U.S. Pat. No. 8,535,934
- U.S. Pat. No. 8,420,380
- U.S. Pat. No. 8,822,203
- U.S. Pat. No 9,247,728
- New Zealand Pat. No. 586901
- New Zealand Pat. No. 600702
- New Zealand Pat. No. 603329
- New Zealand Pat. No. 623220
- Australian Pat. No. 728233
- Japanese Pat. No. 5599322
- Japanese Pat. No. 5746534
- Japanese Pat. No. 5889861
- Australian Pat. No. 2008260409
- Australian Pat. No. 2009212725
- Australian Pat. No. 2013216566
- Australian Pat. No. 2014256394
- Chinese Pat. No. ZL200980110231.5
- Chinese Pat. No. 201310148246.9
- Chinese Pat. No. ZL201310556156.3
Organ Care System (OCS) Heart
- U.S. Pat. No. 7,651,835
- U.S. Pat. No. 6,100,082
- U.S. Pat. No. 6,046,046
- U.S. Pat. No. 7,572,622
- U.S. Pat. No. 8,304,181
- U.S. Pat. No. 8,409,846
- U.S. Pat. No. 8,585,380
- U.S. Pat. No. 8,465,970
- U.S. Pat. No. 9,055,740
- U.S. Pat. No. 9,215,867
- U.S. Pat. No. 9,301,519
- Israeli Pat. No. 182403
- Israeli Pat. No. 211084
- New Zealand Pat. No. 554543
- New Zealand Pat. No. 580648
- New Zealand Pat. No. 591524
- New Zealand Pat. No. 597482
- New Zealand Pat. No. 600702
- New Zealand Pat. No. 608461
- New Zealand Pat. No. 614472
- New Zealand Pat. No. 625575
- Australian Pat. No. 728233
- Hong Kong Pat. No. 1101890
- Hong Kong Pat. No. 1145942
- Hong Kong Pat. No. 1185516
- Belgian Pat. No. 1768490
- Danish Pat. No. 1768490
- European Pat. No. 1768490
- French Pat. No. 1768490
- German Pat. No. 1768490
- Irish Pat. No. 1768490
- Italian Pat. No. 1768490
- Netherlands Pat. No. 1768490
- Spanish Pat. No. 1768490
- Swedish Pat. No. 1768490
- U.K. Pat. No. 1768490
- Japanese Pat. No. 5113522
- Japanese Pat. No. 5462406
- Japanese Pat. No. 5746534
- Japanese Pat. No. 5889861
- Japanese Pat. No. 5933666
- Australian Pat. No. 2005294206
- Australian Pat. No. 2008260409
- Australian Pat. No. 2012216796
- Australian Pat. No. 2013216566
- Australian Pat. No. 2014256394
- Chinese Pat. No. ZL200580042038.4
- Chinese Pat. No. ZL200880020749.5
- Chinese Pat. No. ZL201210449227.5
- Chinese Pat. No. ZL201310556156.3
Organ Care System (OCS) Liver
- U.S. Pat. No. 6,100,082
- U.S. Pat. No. 6,046,046
- U.S. Pat. No. 8,585,380
- U.S. Pat. No. 9,055,740
- New Zealand Pat. No. 600702
- Australian Pat. No. 728233
- Japanese Pat. No. 5746534
- Japanese Pat. No. 5889861
- Australian Pat. No. 2008260409
- Australian Pat. No. 2013216566
- Australian Pat. No. 2014256394
- Chinese Pat. No. ZL201310556156.3
OCS Lung Solution Set
- U.S. Pat. No. 6,953,655
- U.S. Pat. No. 9,078,428
- New Zealand Pat. No. 616699
- Austrian Pat. No. 1017274
- Belgian Pat. No. 1017274
- Danish Pat. No. 1017274
- European Pat. No. 1017274
- Finnish Pat. No. 1017274
- French Pat. No. 1017274
- German Pat. No. 1017274
- Irish Pat. No. 1017274
- Italian Pat. No. 1017274
- Luxembourg Pat. No. 1017274
- Monaco Pat. No. 1017274
- Netherlands Pat. No. 1017274
- Portuguese Pat. No. 1017274
- Spanish Pat. No. 1017274
- Swedish Pat. No. 1017274
- Swiss Pat. No. 1017274
- U.K. Pat. No. 1017274
- Canadian Pat. No. 2304598
- Japanese Pat. No. 5923551
- Japanese Pat. No. 5923552
OCS Heart Solution Set
- U.S. Pat. No. 6,953,655
- U.S. Pat. No. 9,078,428
- Austrian Pat. No. 1017274
- Belgian Pat. No. 1017274
- Danish Pat. No. 1017274
- European Pat. No. 1017274
- Finnish Pat. No. 1017274
- French Pat. No. 1017274
- German Pat. No. 1017274
- Irish Pat. No. 1017274
- Italian Pat. No. 1017274
- Luxembourg Pat. No. 1017274
- Monaco Pat. No. 1017274
- Netherlands Pat. No. 1017274
- Portuguese Pat. No. 1017274
- Spanish Pat. No. 1017274
- Swedish Pat. No. 1017274
- Swiss Pat. No. 1017274
- U.K. Pat. No. 1017274
- Canadian Pat. No. 2304598
- Japanese Pat. No. 5923551
- Japanese Pat. No. 5923552
OCS Liver Sterile Bile Salts Set
- U.S. Pat. No. 6,953,655
- U.S. Pat. No. 9,078,428
- Austrian Pat. No. 1017274
- Belgian Pat. No. 1017274
- Danish Pat. No. 1017274
- European Pat. No. 1017274
- Finnish Pat. No. 1017274
- French Pat. No. 1017274
- German Pat. No. 1017274
- Irish Pat. No. 1017274
- Italian Pat. No. 1017274
- Luxembourg Pat. No. 1017274
- Monaco Pat. No. 1017274
- Netherlands Pat. No. 1017274
- Portuguese Pat. No. 1017274
- Spanish Pat. No. 1017274
- Swedish Pat. No. 1017274
- Swiss Pat. No. 1017274
- U.K. Pat. No. 1017274
- Canadian Pat. No. 2304598
- Japanese Pat. No. 5923551
- Japanese Pat. No. 5923552
This page is intended to serve as notice under 35 U.S.C. 287(a).