Ventracor Chief Executive Officer, Colin Sutton PhD, said "Surgeons at Papworth Hospital in the United Kingdom performed the procedure at the weekend.
"The first implant in Europe is a significant step for the company as it clearly demonstrates the clinical excitement surrounding the potential of the VentrAssist
Chief Medical Investigator at Papworth Dr Steven Tsui said "The operation went according to plan and our patient has been stable during the last 24 hours. Technically, the VentrAssist is easier to implant than many earlier generations of ventricular assist devices. The small size of the pump means that the operation is less traumatic for the patient," Dr Tsui said.
Dr Sutton said participation by Dr Stephen Tsui and his colleagues at Papworth added to the trial's stature and would further accelerate patient enrolment in the CE Mark Trial.
"Over the last couple of weeks, we have implanted seven patients culminating with our first implant outside Australia.
"Ventracor has now implanted the VentrAssist in 23 patients including (nine as part of the pilot trial) and each implant adds to our clinical knowledge and enhances the robust and repeatable patient care protocols used by clinicians to obtain the best results for our patients," Dr Sutton said.
He added Ventracor would carefully expand the number of European hospitals participating in the trial to accelerate acquisition of clinical evidence to support a successful application for European regulatory approval.
"Rikshospitalet in Oslo, Norway is ready to enrol its first patient and we recently met with several leading German heart transplant centres which have all expressed strong interest in participating in our trial program," Dr Sutton said.
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Contact: Andrew Geddes
61-2-9406-3086
Research Australia
25-May-2005