Narval CC™ is indicated to treat adults with snoring or mild to moderate obstructive sleep apnoea (OSA). In case of severe OSA, it is indicated after continuous positive airway pressure (CPAP) therapy failure, non-compliance or refusal.
Please refer to the user guide for relevant information related to any warnings and precautions to be considered before and during use of the product.
1. Vecchierini MF, Attali V, Collet JM, et al. Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. J Clin Sleep Med. 2021;17(8):1695-1705. A 5-year prospective observational multicentre cohort study on 331 OSA patients.
2. Attali V & al. Efficacy and tolerability of a custom-made Narval mandibular advancement device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data. Sleep Med. 2019 Nov;63:64-74
* A 5-year prospective observational multicentre cohort study on 331 OSA patients. 2-year follow-up data analysis. Clinical Trials.gov identifier: NCT01326143
- IOS European Controlled Product Launch (CPL /3shape) – ResMedinternal report, data on file (confidential), January 2017- Chapters 4.2 (Summary from 92 manufactured IOS MRD), 4.3 (Patients, and practitioners, feedback from 63 questionnaires).
Extracts from this ResMed internal report:
- In 98% of cases the practitioner found the scanning process convenient or very convenient (N=47).
- A gag reflex was reported in 6% of cases (N=53).
- Appropriate level of biocompatibility demonstrated by tests based on indications in ISO 10993-1:2009.
- Data on file, confidential: Narval aging test and material degradation assessment.
- Data on file, confidential: Computer mechanical strength simulation study – Narval splints are able to withstand compression forces superior to 500N.