Summary: The OrthoApnea NOA, a 3D-printed nylon oral appliance approved by the FDA in 2021, has been utilized by over 450,000 patients for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring. Developed through a collaborative effort among biomedical engineers, dentists, and sleep specialists, the OrthoApnea NOA leverages biocompatible materials and precise 3D printing technology to offer a customized fit for each patient.
Key Takeaways:
- Adoption: Since its FDA clearance in 2021, the OrthoApnea NOA has been used by over 450,000 patients for treating obstructive sleep apnea and snoring.
- Collaborative Development: The device was developed through a multidisciplinary collaboration among biomedical engineers, dentists, and sleep specialists.
- Advanced Manufacturing: Utilizing 3D printing technology and biocompatible polyamide 12, the OrthoApnea NOA is customized to fit each patient’s unique mandibular biomechanics, aiming to ensure comfort and efficacy in maintaining an open airway during sleep.
OrthoApnea NOA, a 3D-printed nylon oral appliance that received US Food and Drug Administration 510(k) clearance in 2021 for the treatment of mild to moderate obstructive sleep apnea and snoring, has been used by over 450,000 patients since its launch, according to OrthoApnea, manufacturer of the device.
“Since its launch, OrthoApnea NOA has proven to be highly effective in reducing OSA symptoms, significantly improving patients’ sleep quality and overall health,” says Manuel González Gómez, head of international marketing and business development at OrthoApnea. “The adoption of this advanced technology ensures a safe, durable, and highly effective treatment, setting a new standard in the management of OSA.”
Gómez notes that the device was developed through collaboration among biomedical engineers, dentists, and sleep specialists, resulting in a product designed to enhance respiratory function during sleep and boost treatment adherence and patient satisfaction. The device is fully digitally designed and tailored to fit each patient’s unique mandibular biomechanics.
Manufactured with biocompatible polyamide 12 using 3D printing technology, specifically the EOS FORMIGA P110 3D printer, the OrthoApnea NOA leverages scientific and technical advantages, according to the company, such as:
- Biocompatibility and Safety: Polyamide 12 is known for its biocompatibility, chemical resistance, and mechanical durability, making it suitable for prolonged medical use.
- Precision and Customization: 3D printing allows for the creation of highly precise, customized devices. The EOS FORMIGA P110 uses selective laser sintering technology to produce complex and detailed structures.
- Efficiency and Speed: 3D printing enables rapid and efficient production, reducing waiting times and improving patient accessibility and satisfaction.
Mandibular Advancement with OrthoApnea NOA
The OrthoApnea NOA comprises two individual splints that hold the mandible in a forward position to facilitate breathing during sleep. Each splint is customized to fit the patient’s upper and lower teeth and is connected by a mechanism that maintains the jaw in an advanced position, helping keep the upper airway open and preventing obstructions during sleep.
Mandibular advancement is achieved progressively and controlled by exchanging the lower splints. The dentist determines the sequence of gradual advancement, which can be specified in millimeters from the starting point or as a percentage of the patient’s total advancement range.
Photo caption: OrthoApnea NOA
Photo credit: OrthoApnea
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