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 expanded1 criteria donor lungs. The OCS Heart is an FDA approved device for expanded2 criteria donor hearts. The OCS Liver is an FDA approved device for DCD3 and DBD donor Livers.

1. Expanded criteria lungs is defined as donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.
2. Expanded criteria hearts is defined as donor hearts that are deemed unsuitable at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).
3. DCD livers < 55 years old with < 30 mins warm ischemia time and macrosteatosis < 15%.

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

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