Ventracor pilot trial to continue

Sydney-based Ventracor (ASX:VCR) today announced its pilot trial, testing the safety of its VentrAssist artifical heart device, will continue.

The trial's chief medical investigator, Prof Don Esmore of Melbourne's Alfred Hospital, said he expected further implants of the device would take place in the near future. Five implants have been conducted for the pilot trial to date, and up to 10 are expected in total.

The first device to be implanted will have been running in vivo for just under 11 months. Three implanted patients have been discharged and are living at home, and two of the patients have died.

According to the company, the VentrAssist system performed to specifications in all patients. However, it is not clear whether or not the deaths are entirely unrelated to the implantation or performance of the system.

In April, Ventracor was forced to call a trading halt in the wake of a newspaper report which the company said "could be misinterpreted" to suggest the pilot trial would be delayed pending a coronial inquest.

Trisha Lee, public affairs manager at the Alfred Hospital, said today that although all deaths in a clinical trial are referred to the coroner as a matter of course, the hospital has not had heard any further information about a coronial inquest

Ventracor has recently commissioned a new facility for manufacturing its device in Sydney's Chatswood. Initially, the company plans to manufacture enough devices to meet the demands of its clinical trial program for European CE Mark approval, due to begin in mid-2004.

At the time of writing Ventracor shares were steady at $1.33.