Fisher & Paykel Healthcare launches F&P Evora Full, a new full face CPAP mask, in the United States. Evora Full will be available for purchase by durable medical equipment companies starting May 9.
The mask has received FDA 510(k) clearance, paving the way for its sale in the United States, following its launch in Australia, New Zealand, Europe, and Canada.
Justin Callahan, president – North America Operations for Fisher & Paykel Healthcare, says in a release. “The Evora Full marks our entry into the compact full-face mask segment, and our teams have worked hard on achieving a final product that optimizes for both comfort and performance.”
The mask has a floating seal and stability wings that work together to create the next generation of Fisher & Paykel’s Dynamic Support Technology. The seal floats under the nose to provide patients with a clear line of sight, while stability wings keep the seal stable.
“Evora Full is a minimal-contact mask designed to allow patients to move and sleep freely without compromising performance,” says Andrew Somervell, VP products and technology for Fisher & Paykel Healthcare, in a release. “It offers patients full-face performance in a compact size.”
In an internal validation trial conducted by Fisher & Paykel Healthcare on 44 participants in New Zealand in 2020:
- 40 out of 44 participants rated the Evora Full mask’s stability as either “very stable” or “stable.”
- 41 out of 44 participants rated the overall comfort of the Evora Full mask as “comfortable” or “very comfortable.”
- 42 out of 44 participants were able to sleep in their preferred sleeping position while using the Evora Full mask.
The mask comes with three seal sizes (extra small, small to medium, and large) and two headgear sizes (standard and extra large).