CLINICAL DATA
FDA Summary of Safety and Effectiveness:
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf ›› download
Below is selected data from the FDA Summary of Safety and Effectiveness for the
SynCardia temporary Total Artificial Heart.
Patient Ambulation |
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From pages 18 & 19 Approximately 65% of the core Total Artificial Heart patients were out of bed by the 5th day after implant. Two weeks after implant, 60% of core patients were walking more than 100 feet. |
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Cardiac Index |
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From page 20 Prior to implant, patients in need of the Total Artificial Heart had a baseline cardiac index of ≤ 2.0 L/min/m2 which is considered critical cardiogenic shock. Following implantation of the Total Artificial Heart, the patient’s cardiac index immediately increased to an average of 3.0 L/min/m2. |
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End Organ Recovery |
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From pages 23 & 24 Within two weeks of implant of the Total Artificial Heart, liver function had returned to normal and kidney function had improved significantly, trending to normal. |
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NEXT ›› NEJM
*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.
SynCardia temporary CardioWest™ Total Artificial Heart.
