7
HVAD
®
Patient Manual
1.8 Summary of Clinical Study Information Using the HeartWare
™
HVAD
™
System
Finally, a clinical study was performed to evaluate the use of a thoracotomy
approach for implanting the HeartWare
™
HVAD
™
System. The typical way the
surgeon implants the pump is to open up your chest with a single long vertical
incision along your sternum in order to access your heart. In the thoracotomy
approach, the surgeon makes a short horizontal incision between the ribs
on the left side of your chest and attaches the pump to your heart through
that space. Sometimes this technique requires a second small incision on
the upper right side of your chest in order to attach the tube that carries the
blood from the pump to the aorta, which pushes the blood to the rest of
your body. This study showed that implanting the HeartWare
™
HVAD
™
System
through a thoracotomy has similar outcomes as when the pump is implanted
through the usual approach with a single long incision down your sternum.
The risks identied in the clinical trials are described in Section 1.5,
“Potential Complications and Risks”.
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