Genio - Obstructive Sleep Apnea System (OSA)
Genio is the disruptive sleep apnea solution for patients who suffer from moderate to severe Obstructive Sleep Apnea or OSA. Genio is the world’s first and unique battery-free, leadless, full body MR conditional and minimally invasive neurostimulator that was designed and developed with users in mind. By stimulating the hypoglossal nerve bilaterally, Genio maintains your upper airway open while you sleep, allowing you to enjoy restful nights again.
Product Details
Genio® is the world’s first and unique battery-free, leadless and minimally invasive neurostimulator that was designed and developed with the user in mind.
Genio® is indicated for moderate to severe OSA patients (AHI of 15 to 65) who are not significantly overweight, and who cannot tolerate, have failed or refused Positive Airway Pressure (PAP) therapy.
“With Genio®, I’m now getting good night sleep and waking up refreshed. Now when I’m going for my morning swim, I’m realizing that this is how the rest of the world feels like.”
Narelle (63) – Australia
“I’m really happy with it. It‘s really great. And I can recommend it to everyone. Everyone should know about the available treatment options. You don’t have to live with the disease. You can treat it.”
Stefan (51) - Germany
The Genio® neurostimulator is implanted under the chin, through a minimally invasive surgical procedure. The device is placed over the genioglossus muscle, close to the tongue’s hypoglossal nerve. The stimulator’s electrodes are placed in contact with both branches of the hypoglossal nerve resulting in bilateral stimulation of the nerve, which then triggers a slight forward movement of the posterior portion of the tongue. By pairing with the external Activation Chip, this process of stimulation and forward movement helps to maintain an open airway.
As part of your bedtime routine, you connect the Genio® Activation Chip to our special Disposable Patch that you apply under your chin. Together, they transmit energy to the Implantable Stimulator. The nerve stimulation triggers a small forward movement of the posterior portion of the tongue and maintains an open upper airway during sleep. After use, the Activation Chip can be detached from the Disposable Patch and the used patch can be disposed of.
How Genio Works
Genio® is the world’s first and unique battery-free, leadless and minimally invasive neurostimulator that was designed and developed with users in mind. Genio® keeps your airway open during the night, efficiently optimizing your night’s rest and revitalizing your daily life.
Being a minimally invasive surgical second-line alternative to CPAP, the Genio® system consists of 3 essential parts: an implanted neurostimulator and an external Activation Chip connected to a Disposable Patch. The combination of these parts is what makes the Genio® system so comfortable and efficient. After going to the doctor first, you will be referred to a designated clinic for your Genio® therapy.
A small, battery-free and leadless neurostimulator is implanted under the chin. The stimulator’s electrodes are placed bilaterally, in contact with both branches of the hypoglossal nerve. The surgical procedure is very short and minimally invasive. The surgery is performed under general anesthesia and includes making a small incision under your chin. Your body will recover fully from this incision in 6 to 8 weeks.
After the healing period, you will receive customized and personal assistance to show you how your new Genio® solution works. From now on it is also required to shave this area of the chin on a daily basis. During these personal sessions, you will need at least two sleep studies to benchmark and adjust the settings of your Genio® system. Your doctor may need to schedule additional sleep studies to monitor and optimize your Genio® therapy settings.
In order to reach therapeutic levels and optimize your therapy, it is extremely important to use your Genio® system each night and to attend all follow-up appointments scheduled by your doctor.
The impact of OSA
Obstructive Sleep Apnea (OSA) is not only disruptive to your life and that of your partner, but it also has many other health implications, such as higher risk of cardiovascular diseases. If you suspect that you’re suffering from OSA, visit your physician as there are many treatments to help.
What is OSA?
OSA is the most common sleep disordered breathing condition, affecting globally around 936 million people between 30 and 69 years of age, of whom 425 million suffer from moderate to severe OSA, requiring treatment[[Benjafield, Adam V et al. Estimation of the global prevalence and burden of obstructive sleep apnea: a literature-based analysis. Lancet Respir Med 2019 Published Online 9 July 2019 http://dx.doi.org/10.1016/S2213-2600(19)30198-5.]].
OSA occurs when the throat and tongue muscles and soft tissues relax and collapse. It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or completely (apnea) blocked, limiting the amount of air that reaches the lungs. During an episode of apnea or hypopnea, the patient's oxygen level drops, which leads to sleep interruptions.
The degree of severity is measured by the Apnea Hypopnea Index or AHI. This index reflects the number of apneas and hypopneas per hour. Moderate and severe OSA patients require a dedicated therapy according to guidelines published by sleep doctors’ scientific societies.
OSA is a chronic disease, which affects the patient's health and quality of life. OSA prevalence is increasing due to the ageing population and rise in obesity: prevalence exceeds 70% in morbidly obese and diabetic patients[[Logan et al. J. Hypertension; O’Keefe and Patterson, Obes Surgery; Oldenburg et al,, Eur J Heart Failure; Einhorn et al. Endocrine Prac; Basseti et al. Stroke]].
Still, OSA remains significantly underdiagnosed: in 2010, the diagnosis rate for OSA in the United States was estimated to be 15-20%[[Harvard Medical School Division of Sleep Medicine, The Price of Fatigue - The surprising economic costs of unmanaged sleep apnea, December 2010]].
OSA Severity
The degree of severity is measured by the Apnea Hypopnea Index or AHI. This index reflects the number of apneas and hypopneas per hour. Moderate and severe OSA patients require a dedicated therapy according to guidelines published by sleep doctors’ scientific societies.
OSA and health risks
Left untreated, OSA is associated with increased mortality risk and comorbidities, including cardiovascular diseases, depression and stroke.
Clinical studies have shown that the mortality rate of non-treated patients suffering from OSA increases significantly over time[[Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.]]. Untreated OSA is associated with a two-times higher risk of stroke[[Wake up America: a national sleep alert : report of the National Commission on Sleep Disorders Research (1994)]] and a five-times higher risk of cardiovascular mortality[[Young T. et al: Sleep Disordered Breathing and Mortality: Eighteen-Year Follow-up of the Wisconsin Sleep Cohort, Sleep. 2008 Aug 1; 31(8): 1071–1078.]]. OSA increases the risk of heart failure by 140%[[Daniel Bratton. CPAP vs MA Devices and Blood Pressure in Patients With Obstructive Sleep ApneaA Systematic Review and Meta-analysis. Jama 2015]].
Furthermore, there is an elevated prevalence of having OSA with depression, stroke, coronary artery disease, atrial fibrillation or any drug-resistant hypertension. If you think that you’re suffering from OSA, visit your physician as there are many sleep apnea treatments to help you.
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