European approval trial enrolment gathers momentum
Ventracor Limited (ASX:VCR) today said recruitment at CE Mark Trial sites outside Australia was gathering momentum worldwide with the recent implantation of a patient in New Zealand, bringing the total number of patients implanted to 27 – including nine as part of the pilot trial.
Ventracor Limited Chief Executive Officer, Colin Sutton PhD said: "We are now recruiting and implanting in three countries. With our growing clinical experience outside Australia, we are on track to complete the CE Mark Trial and submit an application for approval to quickly begin selling our implantable heart device in the major market of Europe."
"Building a track record of implants enables us to gather information to demonstrate the VentrAssist is safe and efficacious, and then use that data to achieve our regulatory milestones within the predicted timeframe," he said.
"We are developing robust and repeatable treatment protocols, greatly reducing the clinical risks to patients and building confidence with the cardiologists and surgeons that recommend and use the device," Dr Sutton added.
He also noted the first patient outside Australia to be implanted at Papworth Hospital near Cambridge in England was discharged home last week.
Dr Steven Tsui, the consultant cardiac surgeon who leads the Papworth team which performed the operation told BBC Television: "His (the patient's) quality of life has been transformed with the VentrAssist and he can safely go home to wait for a suitable donor heart and have a heart transplant.
"We are very excited to be involved with this clinical trial and so far, we have been most impressed by the device," Dr Tsui said.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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