FDAnews Device Daily Bulletin

FIRST WEARABLE CPAP DEVICE FOR SLEEP APNEA LAUNCHED

March 21, 2006
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Hoffman Laboratories' wearable CPAP (Continuous Positive Airway Pressure) device for the treatment of sleep apnea will be introduced at the Medtrade Spring convention in Las Vegas, the company has reported.

The lightweight BreatheX CPAP device provides up to two nights of therapy with its built-in, rechargeable battery, and is mobile, wearable and comfortable. CPAP users don't have to be "plugged in" to a bedside flow generator with a six-foot hose.

Because the BreatheX, which can be used with most interfaces on the market, looks more like a pillow than a medical device, users won't experience the barriers to acceptance and compliance that they may traditional CPAP devices.

There were substantial engineering challenges to developing a wearable CPAP device. Usually CPAP motors are too inefficient to operate off a small battery pack, are noisy, and produce too much heat and vibration to be used close to a patient. To overcome these obstacles, the BreatheX relies on a patent pending, motor/blower design. This design lends itself to using a lighter, more comfortable headgear and nasal interface system.

"Although the industry trend is toward smaller, less obtrusive, and easier to use CPAP devices, the basic configuration -- a bedside CPAP unit, a six-foot hose, and a patient interface -- hasn't changed for 20 years. We're offering an alternative, in particular for those patients who decline treatment using conventional CPAP therapy or are noncompliant," said Dennis Nasto, vice president of sales and marketing for Hoffman Laboratories.

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