LivaNova's aura6000 System Receives FDA Approval for Obstructive Sleep Apnea Treatment
Key Insights
The FDA granted premarket approval for LivaNova's aura6000 System (search), the first hypoglossal nerve (search) stimulation device approved without contraindications related to complete concentric collapse (search).
The OSPREY randomized controlled trial demonstrated that 65% of patients achieved responder criteria at 12 months, with median apnea-hypopnea index decreasing from 34.3 to 11.0 events per hour.
The proximal hypoglossal nerve (search) stimulation therapy uses six electrodes to provide customizable treatment options for moderate to severe obstructive sleep apnea (search) patients.
LivaNova PLC announced that the US Food and Drug Administration has granted premarket approval for the aura6000 System (search), a hypoglossal nerve (search) stimulation therapy for adult patients with moderate to severe obstructive sleep apnea (search) who have failed, do not tolerate, or are ineligible for first-line therapies such as positive airway pressure. The system represents a significant advancement as the first hypoglossal nerve stimulation device approved in the US without a contraindication or warning related to complete concentric collapse (search).
Novel Therapeutic Approach
The aura6000 System (search) utilizes proximal hypoglossal nerve (search) stimulation (p-HGNS), delivering therapy through six electrodes placed on the proximal trunk of the hypoglossal nerve to access airway-controlling muscles. This approach provides broad access to muscles controlling the airway and offers customizable titration options through what LivaNova refers to as the PolySync algorithm. The system is indicated for patients with an apnea-hypopnea index between 15 and 65.
"FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward for patients struggling with inadequately treated OSA," said Ahmet Tezel, Ph.D., Chief Innovation Officer for LivaNova. "Our p-HGNS therapy underwent a rigorous evaluation for safety and efficacy in the OSPREY randomised controlled trial and delivered clinically significant responses and sustained improvements over time."
OSPREY Trial Results
The FDA approval was supported by data from the OSPREY trial, a prospective, multicenter, randomized controlled trial evaluating proximal hypoglossal nerve (search) stimulation. The no-stimulation-controlled 2:1 randomized controlled trial initiated therapy at month 1 for the treatment group and month 7 for the control group.
At 12 months, 65% of patients in the treatment group met responder criteria, defined as at least a 50% reduction in apnea-hypopnea index and a value below 20 events per hour. The median apnea-hypopnea index decreased from 34.3 events per hour at baseline to 11.6 events per hour at 7 months, with sustained improvement to 11.0 events per hour at 13 months.
The oxygen desaturation index also showed significant improvement, with 69% of treated patients achieving at least a 25% reduction compared with 38% in the control group at 7 months. The median oxygen desaturation index decreased from 35 events per hour at baseline to 13 events per hour at month 7 with treatment.
Complete Concentric Collapse Population
Importantly, the OSPREY study did not exclude patients with complete concentric collapse (search), a condition that has historically been a contraindication for other hypoglossal nerve (search) stimulation devices. Based on a predictive algorithm, the study enrolled patients at increased risk of complete concentric collapse at a ratio aligned with the general obstructive sleep apnea (search) population seen in clinical practice.
Response rates and apnea-hypopnea index reductions with 12 months of p-HGNS therapy for patients with predicted risk for complete concentric collapse (search) were consistent with results for the full study population, demonstrating the robustness of the therapeutic response. The system does not require drug-induced sleep endoscopy prior to implantation.
"We are proud to bring the option of p-HGNS to more patients, as the first and only HGNS device FDA-approved without a contraindication or warning related to CCC and no requirement for a pre-implantation DISE (drug-induced sleep endoscopy)," Tezel said.
Next-Generation Development
LivaNova reported ongoing development of a next-generation device designed to include magnetic resonance imaging compatibility, remote configuration capabilities, and a rechargeable battery with an anticipated lifespan of up to 15 years. The company stated the device is anticipated for release in the first half of 2027, subject to US Food and Drug Administration supplement review.
"FDA approval of the aura6000 System (search) validates our innovative solution that will soon provide a much‑needed alternative for OSA patients who are unsuccessful with PAP and are seeking effective therapy, regardless of complete concentric collapse (search)," said Lucile Blaise, LivaNova's Global Head of Commercialization for OSA. "The system has also been validated with a pivotal study in more severe patients than any other approved HGNS therapy, and we look forward to bringing our next-generation technology to market next year."