ATLANTA – Medtrade East exhibitor Fisher & Paykel Healthcare has announced the United States launch of F&P Evora™ Full, a compact full-face mask for obstructive sleep apnea (OSA) treatment. The mask recently received FDA 510(k) clearance, paving the way for its sale into the United States following its launch in Australia, New Zealand, Europe and Canada.
“We welcome this clearance from the FDA and look forward to offering this unique full-face mask to our customers and patients,” said Justin Callahan, president – North America Operations for Fisher & Paykel Healthcare. “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 optimises for both comfort and performance.”
The mask has a floating seal and stability wings that work together to create the next generation of Dynamic Support Technology™. The compact 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,” said Andrew Somervell, vice president, Products and Technology for Fisher & Paykel Healthcare. “It offers patients full-face performance in a compact size.”
The Evora Full mask clinical trial results show:
- 91% of trial participants rating Evora Full as ‘stable’ or ‘very stable’1;
- 93% found the mask to be ‘comfortable’ or ‘very comfortable’2; and
- 96% were able to sleep in their preferred sleeping position3.
The mask comes with three seal sizes (Extra Small, Small to Medium, and Large) and two headgear sizes (Standard and Extra Large). Fisher & Paykel Healthcare is scheduled to exhibit at Medtrade East, scheduled for Oct. 24-26, 2022 at the Georgia World Congress Center in Atlanta.