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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

patientambulation-small   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.

   

Cardiac Index

cardiac-small   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.

   

End Organ Recovery

liver-small   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.
tah-big

 

NEXT ›› NEJM

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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