New ResMed devices win US approval
Monday, 22 July, 2002
Meditech company ResMed's latest sleep apnoea devices, the S7 Elite CPAP and AutoSet Spirit autotitrating devices, have been approved by the FDA for sale in the USA.
According to ResMed CFO Adrian Smith, the two products have been on the market since late last year in Australia and were approved in France earlier this year. The company is also awaiting approval in Germany.
"We're very happy that the US approval process is finished so we can get on with selling the products," Smith said.
The two products are based on the same platform technology developed by ResMed, with the AutoSet Spirit offering the ability to deal with pressure changes on a breath-by-breath basis. The devices are smaller, lighter and quieter than previous models.
"We believe the AutoSet Spirit is the better technology," Smith said.
Obstructive sleep apnoea is a condition where the upper airways collapse during sleep, briefly obstructing airflow. It is a common condition, affecting one in ten males over the age of 35 and one in five over 60.
According to Smith, the overall market for obstructive sleep apnoea is growing, and in the US is currently worth $US500 million. However, he noted that market penetration is tiny.
"Only 10 per cent of patients with obstructive sleep apnoea are identified and treated in the US," Smith said. "It's a hugely under-treated condition."
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