HeartWare HVAD - Summary of Clinical Study Information Using the HeartWare HVAD System

6
1.0 Introduction
1.8 Summary of Clinical Study Information Using the HeartWare
™
HVAD
™
System
The HeartWare
™
HVAD
™
System has been evaluated in patients with advanced heart
failure in two clinical studies. The rst clinical study was conducted in Europe and
Australia. This study included 50 patients of which 90% successfully reached the study
success point. The denition of success was:
• Being alive on the HeartWare
™
HVAD
™
System for 180 days or
• Receiving a heart transplant within 180 days of having the HVAD
®
Pump implanted
or
• Having the HVAD
®
Pump successfully removed after the patient’s own heart
recovered within 180 days of HVAD
®
Pump implant.
A second, larger bridge to heart transplantation study was performed in the
United States. This study included 140 patients. Of the 140 patients who received
the HeartWare
™
HVAD
™
System as a bridge to heart transplantation in the United
States, 91% reached the study success point. In both these studies, there were
improvements in the patients’ quality of life and their ability to better perform
physical activities with at least 92% of the patients being able to return home after
the HeartWare
™
HVAD
™
System was placed inside the body.
The HeartWare
™
HVAD
™
System was evaluated as a destination therapy in patients
with advanced heart failure who are not on the list for a heart transplant in two
additional clinical trials in the United States. These studies included over 900 patients;
2/3 of the patients received the HeartWare
™
HVAD
™
System, and the other 1/3
received a different pump already approved for destination therapy. The primary
endpoint for the rst clinical trial was being alive at 2 years on support, without
having experienced a severely disabling stroke or having to undergo urgent heart
transplant or require surgery to change the heart pump for a new one due to
problems with the original pump. A severely disabling stroke is a stroke that results in
long-lasting, even permanent side effects that prevent you from being able to take
care of yourself or perform everyday tasks without help. The rst trial showed that in
patients with advanced heart failure who were not on the list for a heart transplant,
the HeartWare
™
HVAD
™
System had similar primary outcomes as the other device
available for destination therapy, and both devices resulted in similar improvements
in the patients’ quality of life and their ability to better perform physical activities.
However, there were more overall strokes in patients who received the HeartWare
™
HVAD
™
System, including more patients who also died as a result of a stroke. The
second clinical study showed that managing patients’ blood pressure may reduce
the risk of these strokes.