today is the day for ventracor, page-45

Vcr has fallen ever since the St vinnies post by HTW(11 april post).Maybe the local doctor paid attention to Paul Jansz. Whether it had anything to do with it i dont know. First HVADTM Implant at St Vincent’s Hospital, Sydney
HeartWare is pleased to announce that on 4 April 2007, the cardiothoracic team at St Vincent’s
Hospital in Sydney, Australia conducted their first implant of HeartWare’s HVADTM Left Ventricular
Assist Device. The device was implanted in a 60 year old male patient with familial cardiomyopathy.
The procedure was completed quickly and without incident and the patient continues to recover well
from the surgery.
The surgical team was led by Dr Paul Jansz, cardiothoracic and transplant surgeon. Dr Jansz
commented:
“Our first clinical experience with the Heartware device was extremely positive. The device was the
smallest device we have used and consequently implantation was remarkably easy. The pump has
worked seamlessly. Our patient has made a relatively straightforward recovery and has now been
discharged from the Intensive Care Unit to the ward. The fact that the pump, once implanted, is
totally contained within the chest cavity means that there is no need for the abdominal surgery
associated with other devices. I am convinced that this pump marks a significant step forward in the
treatment of end stage heart failure.”
Clinical Trial Update
To date, thirteen patients have been implanted with the HVADTM, including five at Vienna General
Hospital, three at Royal Perth Hospital, two at Hannover Medical Centre, two at Harefield Hospital
and one at St Vincent’s Hospital. On a cumulative basis, these patients have been supported for a
total of over 1,500 days.
Sadly, we also report the death on Monday 10th April of one of the patients enrolled in the HeartWare
clinical trial. Despite a successful implant of the HVADTM device, the patient suffered a series of
operative complications that the implanting surgeon feels were entirely unrelated to the pump. As a
company, our goal is to preserve and extend the lives of the patients who receive our implant so we
are deeply saddened by this outcome even though this type of event is common to every LVAD trial.
Now that all of our five centers are open and implanting, we will be providing periodic updates of the
progress of our clinical trial and, as previously disclosed, will not be providing patient-by-patient
implant details or progress. We will however provide relevant details regarding the outcome of our
entire clinical trial following the endpoint of our clinical trial.
The primary endpoint for the HVADTM clinical trial is patient survival to 180 days or transplantation.
Of the thirteen patients enrolled to date, three have successfully met the trial endpoint. These include
HeartWare’s first patient, who has been supported by his pump for 385 days, and HeartWare’s second
and third patients who received heart transplants after 348 and 157 days respectively.