Global Leader in PAP Therapy Makes MRD A Mainstream Sleep Apnea Therapy Option
The 4,000-plus ResMed employees around the world are united by the goal of changing lives by putting a spotlight on the serious health impact of sleep disordered breathing, and engaging the medical and dental communities with innovative, patient-centric products to manage the condition.
Formed in 1989, ResMed is the global leader in developing, manufacturing and selling positive airway pressure – PAP — equipment, but its leadership recognized the need for effective oral appliance therapy as well.
“PAP is the gold standard for the treatment of OSA, but ResMed has always been active in researching other therapy options for patients suffering from sleep apnea,” said Jim Hollingshead, president ResMed Americas. In its quest to better serve all patients, ResMed had to augment its expertise in oral appliance therapy.
In 2002, the development of Narval CC, a custom-made, CAD/CAM-designed mandibular repositioning device (MRD), was started in Lyon, France. The manufacturing platform was unique and scalable and the MRD’s patented design enabled unparalleled patient comfort. Early clinical evidence suggested the Narval CC was achieving excellent results in treating snoring and sleep apnea.
“These attributes led to our 2009 acquisition of the Narval company. We retained their leadership team and transitioned the company into a new dental sleep business unit for ResMed, currently operating across Europe and North America,” said Kristie Burns, general manager, ResMed Dental Sleep.
ResMed’s mission is to increase the awareness of the dangers of undiagnosed and untreated sleep disordered breathing and to improve the quality of life for people with these conditions. “In pursuit of this mission, it makes sense for us to offer multiple, effective therapies. Sleep apnea therapy requires significant patient engagement – even more so than most chronic disease therapies — so we encourage the consideration of what will work for an individual patient’s lifestyle and symptom relief that will still achieve the clinically-measured, positive outcomes.” Kristie added.
ResMed is driving evidenced-based medical research in oral appliance treatment options with its investment in ORCADES. This is a five-year, prospective multicenter study monitoring subjective and objective treatment in patients receiving Narval. Early results have already been shared at the European Respiratory Society in 2013. The rate of treatment success (defined as >50% decrease in AHI) at 3 months follow-up was 84% irrespective of OSA severity or previous use of CPAP in the earliest patient subgroup (n=143). Further publications on efficacy, side-effects and treatment in snoring and mild, moderate and severe obstructive sleep apnea patients are coming soon. This rigorous evidence can have a profound effect on therapy adoption by dentists and sleep physicians. “Sleep physicians consistently tell us that they are skeptical of oral appliance therapy for a variety of reasons, the top two being uncertain efficacy of treatment and medical reimbursement for the treatment,” said Kristie.
“Sleep physicians are used to PAP, where efficacy and reimbursement are very clear. A multicenter study the size of ORCADES can positively address both topics. We have to help payers understand what results are possible with specific customized oral appliances, evidenced by published results.”
ResMed values the opportunity to work with experienced dental sleep professionals as well as sleep physicians to provide untreated patients with access to therapy. Dentists and sleep physicians cannot fully accomplish this working in silos. Kristie shares that this has been a significant challenge.
In an effort to support collaboration between dentists and sleep physicians, ResMed has assembled an experienced team with tools built from its 25 years in sleep apnea treatment. These tools incorporate real-world feedback from physicians. “It will take professional collaboration to get more untreated patients into therapy, and we’re bringing the insights from the physician community to our dentist partners. Team members are experienced in sleep medicine and specialty dental treatments, the combination of which is critical to supporting our customers. Bridging the two communities can accelerate the use of acceptance of oral appliances among physicians,” said Kristie.
Another critical partner in diagnosis and treatment are referral sources, noted Kristie. “The general dentists and primary care physicians that identify symptoms and first educate the patients about this chronic condition need our support.” Just as sleep physicians lecture at grand rounds, dental sleep professionals need to educate general dentists at regional study clubs, state dental meetings and regional sleep society meetings.
“Without this sharing, we perpetuate the uninformed practice of placing splints for snoring along with the potential of intensifying the more serious problem of sleep apnea,” she said. Ideally, general dentists would be active in screening for sleep apnea and refer to local dental sleep experts, just like for oral cancer.
Treating sleep disordered breathing can look like the coordinated care seen in other chronic conditions like diabetes or heart disease; patients and providers working together to match therapy to the individual patient’s unique circumstances. By creating standard protocols that are flexible enough to meet each person’s needs while adhering to proper medical practice, including pre- and post-testing to verify treatment efficacy, ResMed is breaking down existing barriers and improving overall patient outcomes.
Many companies provide products or services to providers in the sleep medicine market. ResMed takes it much further by supporting all parts of the diagnostic, treatment, and follow-up continuum, truly being a partner in health for providers and patients. Changing lives with every breath. For more information on Narval and ResMed, visit www.ResMed.com or attend a free monthly webinar by registering at, www.NarvalCC.com/progress