SynCardia Companion 2 Driver System, Operator'S Manual

Page: 15 / 134

SynCardia Systems, LLC
Companion 2 Driver System Operator Manual
Page 15 of 132
Chapter 2. Indications for Use
2.1 70cc TAH-t Indication for Use
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is indicated
for use as a bridge to transplantation in cardiac transplant-eligible
candidates at risk of imminent death from non-reversible biventricular
failure.
The use of the SynCardia 70cc TAH-t for destination therapy (for patients
who are ineligible for cardiac transplantation and for whom clinical indices
indicate a remote likelihood of becoming eligible for a transplant) is
investigational.
2.2 50cc TAH-t Indication for Use
The SynCardia 50cc temporary Total Artificial Heart (TAH-t) is indicated
for use as a bridge to transplantation in cardiac transplant-eligible
candidates at risk of imminent death from biventricular failure.
2.3 Companion 2 Driver System Intended Use
The Companion 2 Driver System, used with the 50cc TAH-t or the 70cc
TAH-t, is intended for use inside the hospital and on the hospital grounds.