Delivering on Innovation for the Treatment of Obstructive Sleep Apnea
by Tom Barman
Since introducing Narval CC into the North American market a few years ago, ResMed has continued charging forward in its quest to change millions of lives by increasing awareness of the adverse health effects of sleep disordered breathing, as well as by engaging the medical and dental communities to help strengthen collaborative efforts along the continuum of care.
In so doing, ResMed has taken a balanced and meticulous approach to the evolution of its proprietary Narval CC CAD/CAM-designed mandibular repositioning device (MRD) amidst the spectrum of more traditional oral appliances that the dental community has been accustomed to prescribing for the treatment of obstructive sleep apnea (OSA).
Along these lines, ResMed has set the bar high in its adherence to various standards of excellence that have touched all aspects of Narval CC’s evolution – from continued innovation to evidence-based medical research to rigorous quality standards – facets that have collectively validated the clinical value and utility of Narval CC.
At the center of Narval CC’s approach to innovation has been a patient-centric design philosophy that fosters ongoing feedback from ResMed’s customers, including dentists, sleep physicians and other stakeholders in the medical community. Such insights provide clinical and practical perspectives that form the basis for driving new innovations and continuous improvements for the portfolio.
With multiple design variations that address a diversity of clinical needs, there are many intricacies that have been factored into Narval CC’s ongoing evolution (patient comfort, optimal retention, clinical efficacy). And when it comes to new product development, an agile approach – driven by prototyping, continuous testing and granular customer feedback – is employed to ensure that such innovations are optimized for market introduction. And it is precisely this approach that ResMed has taken for its new Narval CC design variation that contacts the anterior teeth – slated for commercial release this winter.
When it comes to clinical performance, Narval’s evolution has and continues to be benchmarked through evidence-based medical research. The ORCADES study, by ResMed, is an ongoing five-year, prospective multi-center study that is monitoring the efficacy of Narval in real-life conditions. Interim results published to-date have been positive, with significant reductions in Apnea Hypopnea Index (AHI) reported, high levels of subjective compliance, beneficial effects on cardiovascular parameters including reduction of blood pressure in patients with hypertension, and improved quality of life. Additional data and results from ORCADES will continue to be published over time. It is intended that this rigorous evidence will raise the bar for oral appliance therapy while increasing attention from sleep physicians.
Behind the scenes, ResMed’s philosophy of continuous improvement is also leveraged for Narval CC and its proprietary CAD/CAM technology, as such improvements enable product innovations to be executed with absolute precision and operational efficiency. Just as companies like Apple and Microsoft continually improve and upgrade their software and operating systems, so, too, does ResMed in its effort to keep Narval current and progressive as the market continues to adopt digital technologies in the dental field.
As a worldwide leader in developing innovative devices and treatments for sleep-disordered breathing, ResMed’s adherence to extremely rigorous quality and regulatory standards are also engrained into its culture. From minor design modifications to new design variations to CAD/CAM technology upgrades, a multitude of quality and design controls are followed to ensure that the final product consistently meets expectations. Risk analysis, software validation and verification, biocompatibility and materials testing, regulatory compliance, and various other checks and balances are routinely employed, and these essentials remain contributing factors to the ongoing success of Narval.
ResMed has pioneered and innovated Narval CC’s proprietary CAD/CAM technology in the North American market. Through concerted efforts focused on product innovation, evidence-based medical research, and rigorous quality and regulatory standards, Narval CC has increasingly earned the trust and confidence of multidisciplinary teams including dentists, sleep physicians and other healthcare professionals as a preferred treatment option for their patients with OSA, further delivering on ResMed’s mission of changing lives with every breath.
For more information on Narval and ResMed, visit www.resmed.com/narval.