LivaNova - Obstructive Sleep Apnea (OSA)

Caution: Investigational device, limited by United States law to investigational use


 

Sleep Apnea Implant Therapy | A CPAP Alternative

LivaNova THN Sleep Therapy is an implantable therapy for the treatment of Obstructive Sleep Apnea (OSA), a very serious condition that affects millions of patients worldwide and occurs when the muscles in your airway relax during sleep, causing your airway to narrow or close as you breath in depriving your brain of oxygen.

This sleep apnea implant delivers therapy through neurostimulation technology and was specifically designed to deliver muscle tone to key tongue muscles, effectively controlling upper airway flow and significantly reducing or eliminating sleep apnea. THN Sleep Therapy is indicated for patients with moderate to severe OSA who are unable or unwilling to use continuous positive airway pressure (CPAP) therapy.

About Obstructive Sleep Apnea (OSA)

  • It is a debilitating, often life-threatening sleep disorder.
  • OSA is extremely common. Prevalence is similar to diabetes or asthma.
  • Over 100 million people worldwide suffer from OSA, of which only 25% are currently being treated.
  • Continuous Positive Airway Pressure (CPAP) device is the established therapy.
  • Loss of tongue muscle tone during sleep causes the obstruction in most patients with OSA.
  • More than 5 million patients own CPAP machines in North America.
  • Studies have shown that more than 46% do not comply with CPAP.

If left untreated, OSA can result in

  • High blood pressure
  • Stroke
  • Heart failure, irregular heartbeats and heart attacks
  • Diabetes
  • Depression
  • Worsening of ADHD
  • Headaches
  • Poor performance in everyday activities
  • Motor vehicle crashes

Sleep Apnea in Numbers...

600
Million Patients Worldwide Suffer from OSA (source WHO 2007)
75
% of OSA Patients are Undiagnosed
165
$ Annual economic cost (billions) of moderate to severe OSA in the US
40
$ US traffic accident costs associated with OSA
 

Freedom to Sleep: No Mask, No Hose

THN Sleep Therapy consists of an innovative, CPAP-alternative, fully implantable device called the aura6000™, which treats obstructive sleep apnea (OSA) by delivering mild stimulation to the tongue during sleep, hence significantly reducing or eliminating sleep apnea events. The aura6000™ system is totally implanted, which means that there are no masks, hoses, mouthpieces or anything else connected to the patient during sleep.

A THN system looks and operates much like a cardiac pacemaker— except that instead of sending pulses to the heart, it sends mild pulses to the hypoglossal nerve in the neck. In fact, the aura6000™ acts like a "pacemaker for the tongue" with the objective of keeping the airway open throughout the night.

THN System Components

Implanted
The aura6000 Implant: a rechargeable battery-powered computer that generates mild stimulation pulses 
The Lead: a cable that carries those pulses to the hypoglossal nerve


External
The Handheld: a remote control that allows patients to start, stop or pause therapy, and to charge the implant

Benefits of THN Sleep Therapy

THN Sleep Therapy consists of a minimally invasive, surgically implanted system for patients that suffer from moderate to severe Obstructive Sleep Apnea. The procedure to implant this "sleep apnea pacemaker" is performed by an ENT surgeon, usually as an outpatient procedure with quick recovery time.

THN Sleep Therapy benefits include:

  1. The Restoration of Normal Sleep Patterns: Designed to deliver muscle tone to key tongue muscles, effectively controlling upper airway flow and significantly reducing or eliminating sleep apnea;
  2. A Simple Procedure: It's less invasive than conventional sleep apnea surgeries, preserving the natural airway anatomy. And the procedure is completely reversible;
  3. The Freedom to Sleep: There are no masks, hoses, mouthpieces or anything else connected to the patient during sleep;
  4. CPAP Alternative: Indicated for people with moderate and severe sleep apnea, who are unable to comply or unwilling to try PAP therapy;
  5. No Side Effects: It doesn’t affect normal speech or swallowing.

 

Publications

Hypoglossal nerve stimulation - Optimizing its therapeutic potential in obstructive sleep apnea (Aug 2014, Journal of Neurological Sciences)

Obstructive sleep apnea is characterized by recurrent periods of upper airway obstruction (apneas and hypopneas) during sleep, leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations and arousals. It is a highly prevalent condition affecting 4 to 24% of men and 2 to 9% of women, and well over 50% of obese individuals. Obstructive sleep apnea is a major cause of morbidity and mortality in Western society and contributes significantly to the development and progression of neurocognitive, metabolic, cardiovascular, and oncologic diseases.

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Introduction: Obstructive sleep apnea (OSA) is a Residual Effect of THN Hypoglossal Stimulation in Obstructive Sleep Apnea. A disease modifying therapy. (Jun 2013, American Journal of Respiratory and

Background: Obstructive Sleep Apnea is a debilitating chronic sleep-related condition where pharyngeal closure leads to temporary breathing cessation inducing falls in oxygen saturation, sympathetic surges and sleep fragmentation. The disease is efficiently treated with continuous positive airway pressure applied through the nose, a symptomatic therapy without residual effect, but the devices used are cumbersome and many patients abandon or refuse the treatment. Hypoglossal nerve stimulation is emerging as an alternative therapy that could have disease modifying properties. Hypothesis: Long-term treatment with Hypoglossal Targeted Neurostimulation could show residual effects through changes in tongue muscle properties or coordination and result in at least temporary abolition of obstructive sleep apnea. Methods: We studied 10 patients with moderate to severe obstructive sleep apnea non compliant with CPAP, after one year THN therapy. Patients had polysomnographic recording with active THN therapy and with THN turned off. Results: THN resulted in significant improvements in the Apnea-Hypopnea index, the 4%Desaturation Index and sleep fragmentation with respect to the diagnostic results at 3 and 12 months therapy. Turning off the stimulation for one night produced no changes in these results: patients remained significantly less affected by sleep apnea than before treatment. Conclusions: THN appears not only as a symptomatic treatment but may have disease modifying properties with residual effects, paving the way to some form of intermittent treatment.

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Targeted Hypoglossal Neurostimulation for Obstructive Sleep Apnea. A 1 year pilot Study. (Feb 2013, European Respiratory Journal)

Continuous positive airway pressure (CPAP) is an effective but cumbersome treatment for obstructive sleep apnoea (OSA). Noncompliant patients need alternative therapies. We studied a tongue neurostimulation approach: targeted hypoglossal neurostimulation (THN) therapy with the aura6000™ System. A multi-contact electrode positioned around the main trunk of the twelfth nerve connected to an implanted pulse generator stimulates segments of the nerve, activating dilator muscles. The primary objective was to improve the polysomnographically determined apnoea/hypopnoea index (AHI) at 3 months, and maintain the improvement after 12 months of treatment. 13 out of 14 operated patients were successfully implanted. At 12 months, the AHI decreased from 45±18 to 21±17, a 53% reduction (p<0.001). The 4% oxygen desaturation index fell from 29±20 to 15±16 and the arousal index from 37±13 to 25±14, both p<0.001. The Epworth sleepiness scale decreased from 11±7 to 8±4 (p=0.09). THN was neither painful nor awakened patients, who all complied with therapy. There were two transient tongue paresis. The present study represents the longest study of any hypoglossal neurostimulation reported to date. We conclude that THN is safe and effective to treat OSA in patients not compliant with CPAP.

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Tongue Anatomy and Physiology, the Scientific Basis for a Novel Targeted Neurostimulation System Designed for the Treatment of Obstructive Sleep Apnea (Jul 2013, Journal of Neuromodulation)

chronic condition that affects millions adults. The effective standard treatment is positive airway pressure (PAP). However, approximately half of the patients that are prescribed PAP are unable or unwilling to comply with this therapy. Untreated OSA ultimately leads to very serious comorbidities. An alternative therapy for this patient population, therefore, is desirable. Hypoglossal nerve (HGN) stimulation is under investigation by multiple groups as a possible alternative therapy for OSA. Objective: To understand the underlying mechanisms of actions related to HGN stimulation, and the implication of this knowledge for specifying and designing a neurostimulation system for the treatment of OSA. Results: Loss of lingual and pharyngeal tone within a narrow airway is the primary mechanism for OSA. Posterior and anterior tongues are different in their anatomy and physiology. Muscle fibers in the posterior tongue are predominantly fatigue resistant that are responsible for the long sustained tonic activities required for maintaining the tongue's position and preventing its mass from falling into the retroglossal airway. The human tongue is a muscular hydrostat and hence would benefit from a sophisticated HGN stimulation system that is capable of achieving a concerted spatio-temporal interplay of multiple lingual muscles, including retrusors. Conclusion: Targeted neurostimulation of the proximal HGN presents as a viable system approach that is far more versatile and physiologic and quite different than prior systems.

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