LivaNova Receives FDA Approval for Clinical Study to Evaluate the aura6000 System to Treat Obstructive Sleep Apnea
Company to launch OSPREY investigational device exemption clinical study in the
An innovative alternative to the traditional continuous positive airway pressure (CPAP) machine, the aura6000 System generates stimulation through a programmable, rechargeable and implantable pulse generator (IPG). The IPG is implanted in a subcutaneous pocket near the clavicle of the patient via an outpatient surgery. Mild stimulation pulses from the IPG are delivered via a lead to the hypoglossal nerve to stimulate the tongue during sleep and help keep the patient’s airway open. With the aura6000, there are no masks, hoses or mouthpieces connected to the patient during sleep.
“The aura6000 is designed to maintain muscle tone of the tongue and upper airway so that airway obstruction and resulting sleep apnea are significantly reduced or eliminated,” said Dr.
With the IDE approval,
“The OSPREY RCT will serve as the confirmatory study for the aura6000 System and its ability to effectively treat OSA,” said
OSA affects approximately one billion people worldwide, yet most cases remain undiagnosed and untreated.1 If left untreated, OSA can have serious consequences including increased rates of death, stroke, hypertension, motor vehicle accidents, heart failure, diabetes, depression and daytime sleepiness.2
For more information on the aura6000 System for the treatment of OSA, visit the
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Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the OSPREY clinical study and the aura6000 System. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended
References
1 Benjafield et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis Lancet Respir Med 2019; 7: 687-98.
2 Knauert et al. Clinical consequences and economic costs of untreated obstructive sleep apnea syndrome
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