Enrollment progress for European approval trial
Sydney 28 April 2005: Ventracor Limited (ASX:VCR) today announced three patients had recently been implanted with the VentrAssistTM implantable heart assist system as part of its CE Mark Trial. Ventracor Limited Chief Executive Officer, Colin Sutton PhD, said two implants were conducted at The Alfred hospital in Melbourne and one at Royal Perth.
Dr Sutton said 20 patients had now been implanted with the VentrAssistTM left ventricular assist system – 11 as part of the current CE Mark Trial which is gathering data to support an application for permission to sell the system in Europe next year.
Dr Sutton added the United States trial of the VentrAssistTM was also on schedule and that the company had received very strong interest from several US clinical study sites.
Ventracor (ASX:VCR) is an international medical technology company that has developed a life-saving heart pump, the VentrAssistTM left ventricular assist system (LVAS) for patients in cardiac failure. The company expects to bring the VentrAssistTM to global markets in record time and capture a significant share of the potentially large LVAS market which independent analysts have estimated could grow to several billion dollars per annum.
The CE mark
In Europe, the letters 'CE' on a manufactured product are a guarantee it meets the essential requirements of the relevant European Directives. For medical device manufacturers like Ventracor, this is the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. Approval to apply the CE mark to a product indicates it can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA).
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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