The mask has 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, VP Products and Technology for Fisher & Paykel Healthcare. “It offers patients full-face performance in a compact size.”
The Evora Full mask is supported by positive clinical trial results:
- 91% of trial participants rating Evora Full as ‘stable’ or ‘very stable’1.
- 93% found the mask to be ‘comfortable’ or ‘very comfortable’2.
- 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).
For more information, visit www.fphcare.com/us/evorafull.
1. 40 out of 44 participants rated the Evora Full mask’s stability as either ‘very stable’ or ‘stable’. Internal validation trial conducted by Fisher & Paykel Healthcare on 44 participants in New Zealand. 2020.
2. 41 out of 44 participants rated the overall comfort of the Evora Full mask as ‘comfortable’ or ‘very comfortable’. Internal validation trial conducted by Fisher & Paykel Healthcare on 44 participants in New Zealand. 2020.
3. 42 out of 44 participants were able to sleep in their preferred sleeping position while using the Evora Full mask. Internal validation trial conducted by Fisher & Paykel Healthcare on 44 participants in New Zealand. 2020.
About Fisher & Paykel Healthcare
Fisher & Paykel Fisher Healthcare is a leading designer, manufacturer and marketer of products and systems for use in acute and chronic respiratory care, surgery and the treatment of obstructive sleep apnea. The company’s products are sold in more than 120 countries worldwide. For more information about the company, visit our website www.fphcare.com.