Ventracor Limited received the award at this year’s design awards. The company is committed to developing and marketing the product to compete with a number of early first and second generation Left Ventricular Assist Systems or LVAS, available in the United States and Europe.
The VentrAssist is a fully implanted ‘third generation’ device that features only one moving part. It assists the heart in pumping blood in the body of patients suffering from ‘end-stage’ congestive heart failure. Congestive heart failure is when the heart is unable to pump blood efficiently throughout the body.
The VentrAssist offers a potential long-term alternative to heart transplant. It does not replace the heart but is connected to a weak heart where it provides permanent support. It has potential to allow the heart to rest and possibly allow it to recover.
Ventracor’s Chief Executive Officer, Dr Colin Sutton, says the company is proud of the recognition from Engineers Australia. He said the award criteria recognised the product’s potential contribution to the national economy, its impact on quality of life and its significance as a benchmark of engineering excellence and an example of world’s best practice.
The total world prevalence of heart disease is estimated at ten to twenty-three million people. The VentrAssist offers an alternative to heart transplant with only 2100 transplants performed in the US each year. The two main types of artificial hearts are total hearts and LVAS, of which there have been three generations.
VentrAssist is one of three third-generation devices currently in clinical trials and is the most advanced of these. It is made from titanium, silicon and rubber and has a diamond-like carbon coating designed to make it ‘biocompatible’.
Patients do not need to take anti-rejection medication. It is six centimetres in diameter and weighs just under 300 grams. Its small size means it can also be used in children.
The VentrAssist pumps blood using a rotating and floating impeller. The hydro-dynamically suspended impeller is the only moving part in the device. An externally worn battery and controller provides power and control.
Current battery technology enables operation of the device for periods of up to eight hours between battery recharging.
Ventracor is undertaking a pilot trial of the VentrAssist device at the Alfred Hospital in Melbourne. So far five patients have been implanted with the device. The selected patients were close to death and ineligible for heart transplant.
Professor Don Esmore, founder and head of the heart and lung transplant unit at the Alfred, is the surgeon in charge of the trial. Up to ten implants will need to be performed by the end of the pilot trial. Once the trial has been completed satisfactorily and the safety of the device is confirmed, enrolments for the European approval mark trial will begin.
Ventracor recently announced the commissioning of a new clean room manufacturing facility at its Sydney headquarters. The new facility will allow the devices to be manufactured totally in-house in Australia by Ventracor. Fifty-five devices required for the European trial will be manufactured at the site.
Construction of the facility will cost $3 million, with an additional $7 million required for further development. Ventracor is predicting a $100,000 price tag for its VentrAssist device, a cost in line with other LVAS.