Circadiance has launched the SleepWeaver 3D Soft Cloth CPAP Mask in the United States. This launch follows the recent FDA 510(k) clearance to market for this mask.

SleepWeaver 3D is soft, light, quiet, and does not cause facial irritation from plastic, according to Circadiance.

“The SleepWeaver 3D Mask provides a soft, loose fitting, light weight, and great sealing alternative to the tight fitting, hard plastic masks. The mask is easy to fit, and unlike hard plastic masks you don’t have to over-tighten the straps of the mask to get a great seal,” says David Groll, CEO of Circadiance, in a release. “SleepWeaver 3D promotes sleep health for obstructive sleep apnea (OSA) and other CPAP and bilevel users.”

Tom Lucas, director of global sales at Circadiance, says, “The beauty of SleepWeaver 3D is the new interface design that allows a loose fit while providing a comfortable, reliable seal to the OSA patient. The SleepWeaver 3D features include a new wing-shaped stay that routes the headgear under the ears, ensuring comfort and a great fit.”

The SleepWeaver 3D Soft Cloth Nasal CPAP Mask is intended to provide an interface for continuous airway pressure (CPAP), AutoCPAP, or bilevel therapy. It is intended for single-patient reuse in the home and single-patient reuse in the hospital/institutional environment. It is indicated for use in patients greater than 66 lbs (30 kg).

The SleepWeaver 3D mask will be shown at the Focus on Respiratory Care & Sleep Medicine Conference on May 5, 2017 in Orlando, Fla.