Ventracor ramps up manufacturing capacity for European trials

Ventracor (ASX:VCR) today announced it has commissioned a new facility for manufacturing its VentrAssist artificial heart device. VCR will expand its current clean-room space, establishing a 260 square meter clean room and manufacturing facility in Sydney’s Chatswood.

The facility is expected to be at full operating capacity in the next 2 to 3 months.

The company says that this financial year it expects to spend $3 million on the facility.

Initially, Ventracor will manufacture sufficient devices to meet the demands of its clinical trial program for European approval, due to begin in mid-2004. The company has previously indicated that up to 30 implants would be required for this program.

Dr Colin Sutton, Ventracor’s Chief Executive Officer, says the facility is also expected to meet global demand for VentrAssist. Clean rooms are essential for the production of high-technology equipment such as implantable medical devices, satellites and silicon chips.

The new facility gives Ventracor engineers and technicians a manufacturing area in which electrostatic discharge, air quality, temperature, humidity and pressure can be controlled.

Air in a clean room is constantly filtered to remove dust particles and impurities. Ventracor has installed an ISO 14644-1 class 6 and class 8 clean room. Class 6 indicates no more than 35,200 particles larger than 0.5 microns per cubic meter of air.

“This is a major capital investment that will help guarantee the future growth of Ventracor,” said Sutton.

Ventracor’s VentrAssist left ventricular assist system is designed as a permanent alternative to a heart transplant for patients suffering end stage heart failure.

A clinical trial to establish the safety of the heart is continuing at The Alfred hospital in Melbourne.