SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 3
1.0 Device
Description
The SynCardia temporary Total Artificial Heart (TAH-t) system is a pulsatile biventricular
device that replaces a patient's native ventricles and valves and pumps blood to both the
pulmonary and systemic circulation. The system consists of the implantable SynCardia
TAH-t and an external console connected by drivelines (Figure 1).
Figure 1: SynCardia TAH-t System
1.1
The Implantable SynCardia TAH-t
The implantable SynCardia TAH-t consists of two artificial ventricles, each made of a
semi-rigid polyurethane housing with four flexible polyurethane diaphragms
separating the blood chamber from the air chamber. The diaphragms allow the
artificial ventricle to fill and then eject blood when compressed by air from the
external console. Mechanical valves, mounted in the inflow (27mm) and outflow
(25mm) ports of each artificial ventricle, control the direction of blood flow. The
maximum dynamic stroke volume of each ventricle is 70 ml, which allows for
generating a flow rate up to 9.5 liters per minute.
The left artificial ventricle is connected via the left atrial inflow connector to the left
atrium, and via the aortic outflow connector to the aorta. The right artificial ventricle
is connected via the right atrial inflow connector to the right atrium and via the
pulmonary artery outflow connector to the pulmonary artery. Each artificial ventricle’s
driveline conduit is tunneled through the chest wall. The right and left artificial
ventricle’s driveline conduits are attached to seven-foot pneumatic drivelines that
connect to the back of the external console.
