Sommetrics Earns FDA Clearance for cNEP External Airway Management Device

Sommetrics, a medical technology company focused on developing products for assessing and managing sleep problems, earned FDA clearance to market its cNEP Airway Management system as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration. This device is intended for use in cases of mild to moderate sedation with non-propofol drugs.

“Our airway management system is an outgrowth of our program to prevent airway collapse in those with sleep apnea”, says Richard M. Rose, MD, president and CEO, in a release. “The airway management device utilizes our proprietary cNEP technology to prevent apnea caused by sedation in the acute care setting. Compared to the current approaches, which utilize invasive devices to keep the airway open, our device is applied externally and is remarkably simple to use. As a study to be published in the journal Endoscopy demonstrates, this device is highly effective, safe and well tolerated by patients.”

cNEP involves the application of external negative pressure over the upper airway via the use of a soft collar. In the case of the cNEP Airway Management device, the collar is attached to wall suction present in the majority of acute care settings. Sommetrics supplies both a single use collar in various sizes, as well as a vacuum regulator, which provides a constant level of negative pressure found to be safe and effective in clinical testing.

David Hillman, MBBS, FANZCA, chief of the Department of Pulmonary Physiology and Sleep Medicine at Sir Charles Gairdner Hospital, Perth, Australia, says: “The cNEP AMS is a welcome addition to the array of interventions available to prevent airway collapse in the peri-operative setting. Airway compromise due to sedatives is common, and a leading cause of respiratory complications. I expect cNEP AMS will become a useful part of our approach to preventing these problems. It’s so easy to apply, it can be used by physician and non-physician members of the healthcare team.”