MicroMedical's human heart trials imminent

Australia's first artificial hearts are to be implanted in human patients within weeks, according to the developer.

Sydney-based MicroMedical Industries (ASX: MMD) said it was preparing to begin placement trials of its VentrAssist device at Melbourne's Alfred Hospital.

The trials, to be led by heart surgeon Professor Don Esmore, are intended to ensure the artificial heart is "anatomically correct".

The company's corporate communications manager Julie Meldrum said the device would be placed in as many as six end-stage cardiac failure patients.

"What these trials are aiming to find out is whether the device it anatomically suitable for a wide range of patients with congested heart failure and they will also give us the opportunity to determine the best position for it in the body," Meldrum said.

In the placement trials an inert VentrAssist Left Ventricular Assist Device (LVAD) will be implanted for 10 minutes in consenting patients undergoing open-heart surgery.

Meldrum said that full transplant trials were expected to follow later in the year.

In a statement, group managing director and CEO Michael Spooner said the placement trials marked a significant milestone in the completion of the VentrAssist R&D program.

"Following the culmination of four years of exclusive R&D effort for the company we know the VentrAssist device works. The design is finalised and the device has been transferred to manufacturing to support the human placement trials," Spooner said.

"Now our focus is on the international approval and commercialisation process for VentrAssist. By concentrating on the international regulatory process we will be able to minimise the time to market."

The trial process was dependent on regulatory process, he said.

The listed company estimates the world market for the VentrAssist at about 800,000 people each year who enter end-stage cardiac failure but who can not access or do not qualify for one of the 4000 annual heart transplants.

The market is estimated at between $US10 billion and $US20 billion annually.

The company describes the device as a hydronomically-suspended centrifugal blood pump system designed to give permanent left heart support.

It claims the artificial heart is clinically superior to competing devices because of the absence of seals, shafts and bearings that can cause blood damage and clotting.

The device is not intended to replace the diseased heart, which remains in place, but to take over as much of the heart's function as necessary.

A controller, worn on the patient's belt, regulates the level of assistance needed via a battery-powered, sensorless "estimator of physiological demand".

The artificial heart has been designed for implantation in patients of any age, including children.

MicroMedical Industries, which also develops portable cardiac monitoring and telemedicine systems, listed on the Australian Stock Exchange in August, 1993.