FDA Approves Novel Nerve Stimulation Device for Obstructive Sleep Apnea

The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 system, a novel hypoglossal nerve stimulation (HNS) device developed by LivaNova, to treat moderate to severe obstructive sleep apnea (OSA) in adults. This approval marks a significant advancement for individuals who have not benefited from or are unable to use continuous positive airway pressure (CPAP) therapy, considered the gold standard treatment for OSA.

How the aura6000 System Works

The aura6000 system utilizes proximal hypoglossal nerve stimulation (p-HGNS). The device consists of a pulse generator implanted under the skin near the clavicle, which delivers targeted electrical pulses to the hypoglossal nerve. This nerve controls the muscles in the tongue. By stimulating this nerve during sleep, the aura6000 encourages the tongue to move forward, preventing airway collapse and reducing breathing pauses associated with OSA. Medical Device Network

Clinical Trial Results: The OSPREY Trial

The FDA’s approval was supported by data from the OSPREY trial (NCT04950894), a multicenter, randomized, sham-controlled study. The trial involved 150 patients and demonstrated significant improvements in OSA severity with the aura6000 system. Key findings include:

• A 58.2% response rate (defined as a 50% or greater reduction in Apnea-Hypopnea Index (AHI) to below 20 events per hour) in patients receiving active treatment compared to 13.5% in the control group at 6 months (P<0.001). LivaNova Investor Relations
• Patients using the device reported improvements in daytime sleepiness and sleep quality.
• The median AHI decreased from 34.3 events per hour at baseline to 11.6 events per hour after 6 months of use, remaining stable at 12 months.
• A 12-month response rate of 65% was observed, along with a 68% reduction in AHI and oxygen desaturation events per hour.

Safety Profile

The OSPREY trial indicated a favorable safety profile for the aura6000 system. The most commonly reported adverse events included incision discomfort, stimulation discomfort, and wound healing issues. Notably, no serious adverse events were attributed to the device. LivaNova Investor Relations

Expanding Access to HNS Therapy

Unlike some previous HNS devices, the aura6000 system does not require drug-induced sleep endoscopy for enrollment and does not have a contraindication or warning related to complete concentric collapse. This broader inclusion criteria potentially expands access to HNS therapy for a wider range of OSA patients. LivaNova Investor Relations

Availability

LivaNova anticipates launching the aura6000 system in 2027. The company is currently preparing a PMA supplement application to the FDA. Med-Tech Insights, Medical Device Network

Understanding Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) affects approximately 30 million people in the United States. Medical Device Network It is characterized by repeated interruptions in breathing during sleep, leading to reduced oxygen levels and fragmented sleep. Common symptoms include loud snoring, daytime sleepiness, and morning headaches. While CPAP remains the first-line treatment, many patients discover it challenging to adhere to due to discomfort.