Regulatory & Patents

Regulatory

The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.

The following safety and performance information is for EU customers and patients, as required by EU medical device regulations:

OCS Lung

OCS Heart

OCS Liver

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 for procurement and transplantation 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

This page is intended to serve as notice under 35 U.S.C. 287(a).