Heart Failure Patient first to have
HeartWare’s HVAD Mechanical Circulatory Assist Device Implanted
March 24th, 2006
The first patient,
a 48 year old male with heart failure, received an implant of the
HeartWare’s HVAD mechanical circulatory assist device on March 22nd,
2006 at the Vienna General Hospital in Austria.
The surgical team
was lead by Dr. Georg Wieselthaler, who is the Clinical Director of
Mechanical Circulatory Support with the University of Vienna commented
on the progress of the patient, "Our first clinical experience of the
HVAD was extremely positive. The procedure was completed quickly and
without incident, and our patient's early post-operative recovery has
been excellent. The device's small size and configuration facilitated a
relatively fast implant procedure. The surgery took only 85 minutes,
significantly less than the time typically required to implant other
devices. The patient was moved from the operating theatre into the post
operative recovery area, conscious and off ventilation within seven
hours. He continues to recover quickly and has met with his family. We
are very pleased with these results."
This is a clinical
trial that has so far been successful for the HeartWare’s HVAD device.
The trial has the goal for implanting 20 patients with advanced heart
failure with the HVAD to complete the study. The implants will be
conducted in various hospitals across Europe. The HeartWare trial
should have the enrollment complete for the 20 patients by the end of
2006. The study result are hoped to be able to be submitted for
approval in the early part of 2007. HeartWare hopes that the approval
for the HVAD will be during the 2nd half of 2007.
is the smallest full output long term circulatory assist device that is
currently in development. HeartWare believes that their HVAD device is
the only one of its kind that can be implanted in the area right next to
the heart where others implant in the abdomen.
The HVAD device is
hoped to improve the quality of the patient’s health by reducing
anticoagulation medication, reduced risk of stroke, and an improved
reliability and durability of the device. The procedure to implant the
device will be less traumatic and the patient will recover faster and
have fewer post operative complications.
Books on Heart Disease
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