FDA considering new sleep apnea device

BETHESDA, MD.; February 20, 2014

But they could have a good alternative soon.

A C-PAP mask and machine is the standard solution now.

It is a tight-fitting mask worn at night. It works, but many people don't like to, or can't wear it.

But the Inspire II upper airway stimulator could be an option. It works like a pacemaker to keep the airway open.

Advisors to the Food and Drug Administration are considering its approval.

Inspire II has one wire which monitors breathing, and another connected to a nerve in the jaw.

When it's turned on at night, it gently stimulates that nerve to keep the tongue from blocking the airway.

In tests at 22 international sites, it reduced breathing interruptions and raised blood oxygen levels in about two-thirds of the patients.

Episodes of breathing pauses declined from 29.3 per hour to an average of 9 per hour.

After the initial study phase, patients were doing well after one year were taken off the device. Doctors saw the number of breathing pauses shoot back up.

The drawback of the stimulator is it requires surgery to implant.

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