Estimated reading time: 2 minutes
Airway Management proudly announces a historic milestone with the FDA clearance of Nylon flexTAP®, the world’s first digitally printed single-point midline oral appliance device for sleep apnoea. This revolutionary device redefines patient care by combining cutting-edge patented Vertex Technology® with unparalleled comfort and efficacy, now FDA cleared for mild to moderate obstructive sleep apnoea (OSA).
Key Features and Benefits
- Digitally Printed Medical-Grade Nylon: Utilises advanced digital printing for a precise, custom-fit design that prioritises patient comfort.
- Patented Vertex Technology: Enables dual-axis movement to maximise airway space, reducing the need for excessive protrusion—ideal for patients with larger tongues or narrow airways.
- 17mm Range of Advancement: Features precise 1/3 mm increment adjustments for optimal mandibular protrusion, improving airway patency.
- Ultra-Thin Custom TAP Trays: Offers maximum comfort without compromising treatment effectiveness. The Thinnest Custom TAP yet.
- BPA-Free and Metal-Free: Crafted with biocompatible materials for enhanced safety.
- No Bite Registration Required: Simplifies the fitting process, saving time for clinicians and patients.
- Mouth Shield and AM Aligner® Included: The only oral appliance to include a nasal breathing accessory improving efficacy. The AM Aligner is a morning exercise tool mitigating common side effects associated with oral appliance therapy.
- 4-Year Warranty: Ensures long-term reliability and confidence.
“We are thrilled to introduce the Nylon flexTAP, a game-changer in oral appliance therapy,” Airway Management CEO Charles Collins said.
“Feedback from key opinion leaders in our TAP Sleep Care system highlights its superior effectiveness and patient comfort. Peer-reviewed studies also confirm that our patented mouth shield, which promotes nasal breathing, significantly improves treatment outcomes. This innovation underscores our commitment to advancing sleep health.” ∞
Manufactured in the USA, the device is now available through Airway Labs, with PDAC coverage (E0486) pending.
