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re: vcr newspaper Ventracor trial faces long delay
By Brian Robins
March 12, 2004

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The resumption of trials of Ventracor's VentrAssist heart device has been delayed as The Alfred - the Melbourne hospital where the trials are being conducted - carries out a thorough review of the device.

Earlier this week Ventracor said in a statement to the Australian Stock Exchange that it was "satisfied with the performance of VentrAssist in all patients who have participated in the pilot trial".

Earlier this month a patient died who had been implanted with the VentrAssist device.

This is the second patient to die, out of the five patients who have received the device so far.

The trial was intended to extend to 10 patients, although no further patients have been scheduled for an implant at this stage, a spokeswoman for the hospital said.

"We're still reviewing it," the hospital spokeswoman said of the Ventracor device. "Our people - doctors and ethics committee - are reviewing it.

"They felt it was important to review it fully."

She said the review could take as long as a coronial inquest - up to two years - although it would probably be less.


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"We are not a private research company. We work differently," she said.

Ventracor's chief executive officer, Colin Sutton, said coroner's inquests would be held into all fatalities.

"The inquiry may be wrapped up promptly. The coroner's report could take some months," he said.

An added inducement for a thorough assessment of the device is the fact that the trial program is now at the halfway mark, the hospital spokeswoman said.

While Ventracor is confident of the VentrAssist device, the study under way at The Alfred is aimed at a wider assessment of the role of the device.

"[The review] will look at whether the device works - and is safe inside a person," the spokeswoman said.

Ventracor's shares fell 11c yesterday to close the day's trading at $1.60. That is a 29 per cent discount to the $2.25 price that shares were issued at in a $67 million placement and rights issue made last year.

"We would expect the hospital to be thorough," Ventracor's Mr Sutton said.