ZOLL’s remedē® System Recognized in Updated AASM Guidelines as Breakthrough Therapy for Central Sleep Apnea
ZOLL®, an Asahi Kasei company and a leader in medical device innovation, has announced a significant milestone for its remedē® System, an implantable therapy for central sleep apnea (CSA). The latest guidelines issued by the American Academy of Sleep Medicine (AASM) have officially recognized transvenous phrenic nerve stimulation (TPNS)—a therapy uniquely offered through ZOLL’s remedē® System—as a recommended treatment option for patients suffering from CSA. This update marks the first major revision to the guidelines since 2012 and signals an important shift in how clinicians approach the management of this serious sleep disorder.
Why the Update Matters
Central sleep apnea is a complex condition that occurs when the brain fails to send consistent signals to the muscles responsible for breathing. Unlike obstructive sleep apnea, which results from physical blockage of the airway, CSA originates in the central nervous system. This makes it more difficult to manage and often more dangerous, as it is strongly associated with other serious health issues such as heart failure, coronary artery disease, and cardiac arrhythmias.
Until now, treatment options for CSA have been limited and often unsatisfactory, focusing primarily on therapies like adaptive servo ventilation (ASV), positive airway pressure, or supplemental oxygen. While some patients have benefited from these interventions, many continued to experience poor sleep quality, excessive daytime sleepiness, and increased cardiovascular risks.
The AASM’s decision to include TPNS in its updated guidelines acknowledges the therapy’s unique ability to address CSA at its root cause—by stimulating the phrenic nerve to restore natural breathing rhythms. This recognition highlights TPNS as one of the most important innovations in the field of sleep medicine in over a decade.
What is TPNS and How Does it Work?
Transvenous phrenic nerve stimulation (TPNS) is a breakthrough approach that works by implanting a device similar in concept to a cardiac pacemaker. The remedē® System delivers gentle electrical pulses to the phrenic nerve via a lead placed in the vein near the nerve. These pulses stimulate the diaphragm, prompting the body to resume normal breathing during sleep.
Unlike mask-based therapies, which can be uncomfortable and difficult for patients to adhere to, TPNS operates automatically and without requiring patient intervention each night. Once implanted, the device monitors breathing and responds as needed, ensuring that sleep patterns remain stable.
Clinical studies have shown that the remedē® System not only reduces the number of central apnea events but also significantly improves oxygen saturation, sleep architecture, quality of life, and cardiovascular outcomes.
Key Highlights from the New Guidelines
The AASM’s updated guidelines place TPNS alongside only a few other evidence-based therapies for central sleep apnea. Importantly, TPNS is the only new therapy added since 2012, underscoring its clinical significance.
The guidelines emphasize several important shifts in how CSA should be managed:
- Patient-Centered Outcomes Over Disease Metrics
Rather than focusing solely on eliminating apnea events, the new approach prioritizes improvements in quality of life, daytime function, and cardiovascular health. TPNS has demonstrated benefits across these domains, making it highly relevant for patients whose daily well-being is compromised by CSA. - Therapies for Primary CSA and CSA Linked to Heart Failure
TPNS is recommended not only for patients with idiopathic (primary) CSA but also for those whose condition is secondary to heart failure—a group for whom treatment options have historically been limited and less effective. - Re-Evaluation When Events Persist
The guidelines advise clinicians to reconsider underlying risk factors and alternative treatment options if CSA events continue despite initial therapy. With TPNS now officially recognized, physicians have an evidence-based tool to offer patients when traditional methods fall short.
Dr. Nancy Collop, Professor of Medicine and Director of the Emory Sleep Center, highlighted the importance of this reframing of care:
The new guidelines call on clinicians to reframe central sleep apnea management, moving toward individualized care that centers on improving quality of life. TPNS is recognized as an important innovation backed by clinical data that shows a real patient benefit.
Clinical Impact of TPNS
The inclusion of TPNS in the guidelines is supported by robust clinical evidence. Research has shown that TPNS can deliver meaningful improvements in multiple patient-relevant outcomes:
- Reduction in Central Events: Patients treated with TPNS experienced fewer episodes of central apneas per hour, reducing sleep disruptions.
- Improved Oxygenation: The oxygen desaturation index improved, helping patients avoid the dangerous consequences of repeated low-oxygen episodes during sleep.
- Better Sleep Architecture: By stabilizing breathing, TPNS helps restore natural cycles of deep and restorative sleep.
- Enhanced Quality of Life: In clinical trials, 78% of patients reported meaningful improvements in quality of life after receiving the remedē® implant.
- High Patient Satisfaction: An impressive 95% of patients stated they would choose to undergo the procedure again, underscoring its tolerability and life-changing impact.
Equally significant, TPNS and ASV are the only therapies in the updated guidelines shown to improve cardiovascular outcomes—a critical consideration for patients with CSA related to heart disease.
ZOLL’s Commitment to Patient-Centered Care
ZOLL encourages sleep physicians and specialists to carefully review the updated AASM guidelines and to consider TPNS as part of the treatment pathway for eligible patients. The company emphasizes that the remedē® System offers not just a technological solution but also a new paradigm in managing a condition long overlooked in sleep medicine.
The remedē® System stands out as the first and only FDA-approved non-mask therapy for CSA. For patients who have struggled with adherence to mask-based treatments or experienced limited benefits, TPNS provides a new, clinically validated option.
Broader Context: Sleep Apnea and Public Health
Sleep apnea in all its forms is increasingly recognized as a significant public health issue. Untreated CSA is not only associated with fatigue and poor daily functioning but also with increased risks of heart failure progression, arrhythmias, hypertension, and even mortality.
By expanding treatment options and reframing the approach to management, the AASM guidelines represent progress toward reducing these risks at a population level. With TPNS now available as a recommended therapy, thousands of patients stand to benefit from better outcomes and an improved quality of life.
