Ventracor Chief Executive Officer Colin Sutton PhD said: "All patients in the US, Europe and Australia have had their controllers exchanged without incident.
"Recruitment in our clinical trial program has been progressing well with three US patients implanted to-date, bringing the total number, including the completed Pilot Trial, of VentrAssist implants to over 30 globally," Dr Sutton said.
As noted previously, Ventracor is currently undertaking additional screening and quality control to ensure the anomaly identified in the cable supplied to it is eliminated.
Dr Sutton said the field exchange and additional screening will delay Ventracor's global clinical trial program, including the CE Mark and US Feasibility trials which were targeted for completion by the end of the 2005 calendar year.
"However, we expect both milestones will be achieved within the first quarter of the 2006 calendar year.
"We do not expect this to adversely impact our progress and the achievement of key milestones in the longer term.
"The costs incurred in the field exchange program are not material in the context of our overall financial commitment to our global clinical trial program.
"Throughout this process, we will ensure the market is kept progressively informed on a timely basis," Dr Sutton said.
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Contact: Andrew Geddes
61-2-9406-3086
Research Australia
11-Oct-2005