EU approves Compumedics sleep system

A European window of opportunity has opened for sleep disorders device developer Compumedics, with the news it has gained EU approval to market its Somte system.

Executive chairman David Burton said the company also expected to receive FDA approval with weeks to market the sleep-cardiology recording system in the US.

Describing the European Union approval as a major milestone for the company and healthcare providers worldwide, Burton said the device would help diagnose the 50 per cent of congestive heart failure patients whose illness was caused by a sleep disorder.

Burton said the Sleep Heart Health Study of 6000 patients across the US suggested that people with sleep apnoea, who stopped breathing several times a night, might suffer heart disease because of the added strain put on the muscle by the condition.

He said he believed the Somte system, which combined a "heart-holter" cardiac recorder with obstructive sleep apnoea monitoring, was the only one of its type in the world.

"For the first time, physicians will have a cost-effective tool which will allow for quick diagnosis in the home and clinic for effective therapy of heart disease associated with sleep disordered breathing," Burton said.

"Achieving the European Union CE Mark will immediately allow Compumedics to provide Somte into the European medical arena," he said.

Burton said the system had just begun to be sold in Australia, with most of the company's marketing efforts focused until now on Japan where an agreement with home healthcare company Teijin had given Compumedics access to 60,000 patients and a large groups of heart specialists.

"This is for people who may have some heart disorder diagnosed but don't know the reason behind their illness," he said.

"It's a method to determine if they have sleep disordered breathing and whether that is a possible link to their heart disease."

At the time of writing, Compumedics shares had risen 10 per cent to 66 cents after a high of 77 cents on the back of the announcement.