Table 5B: Long-term mechanical circulatory support devices and manufacturer.
| Device | Manufacturer | Remarks |
|---|---|---|
| Intracorporeal ventricular assist devices | ||
| INCOR® | Berlin Heart | First implant 2002, CE mark 2003 |
| HVAD® | Medtronic | CE mark 2008, FDA approval BTT 2012, FDA approval lateral implantation 2015 |
| HeartMate II® | Abbott Laboratories | First implant 2003, FDA approval BTT 2008, DT 2010 |
| HeartMate 3® | Abbott Laboratories | First implant 2014, CE mark 2015 |
| EVAHEART 2® | Evaheart Inc. | First implants 2005 in Japan, IDE approval by FDA, BTT trial ongoing |
| Jarvik 2000® | Jarvik Heart | First implant 2000, CE mark 2005, FDA approval BTT 2005, DT trial ongoing |
| Heart Assist 5® | Reliant Heart Inc. | First implant 1998, CE mark 2001, BTT trial ongoing |
| Paracorporeal ventricular assist devices | ||
| EXCOR® | Berlin Heart | First implant 1990, CE mark 1996 |
| Total artificial heart | ||
| SynCardia TAH® | SynCardia | First implant 1986, FDA approval BTT 2004 |
| Carmat TAH® | Carmat SA | First implant 2013, investigational device |
BTT = bridge to transplantation; CE = Conformité Européenne; DT = destination therapy; FDA = US Food and Drug Administration; IDE = investigational device exception; TAH = total artificial heart.