LivaNova Earns FDA Approval for Neurostim for Sleep Apnea

LivaNova has gained U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its aura6000 system to treat adults with moderate to severe obstructive sleep apnea (OSA).

The system employs proximal hypoglossal nerve stimulation (p-HGNS) to treat OSA in patients with an apnea-hypnopnea index (AHI) between 15 and 65 who have failed, don’t tolerate, or are ineligible for first-line therapies like positive airway pressure (PAP).

p-HGNS therapy uses six electrodes placed on the proximal trunk of the hypoglossal nerve. It provides broad access to the muscles controlling the airway and a wider set customizable titration options to reduce or eliminate airway obstruction and sleep apnea. The latter is referred to as the PolySync algorithm.

“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 randomized controlled trial and delivered clinically significant responses and sustained improvements over time. Now, with FDA approval secured, we are advancing the device toward an even more sophisticated, next-generation system for patients and, ultimately, commercialization.”

The company continues to prepare its next-gen OSA device for a PMA supplement application to the FDA. The device is being designed for compatibility with MRI, remote and secure configuration management capabilities, and rechargeable battery tech that lasts up to 15 years.

Data from OSPREY Trial Supports FDA Approval

The no stimulation-controlled 2:1 RCT, with therapy initiated at month (M) 1 (treatment) and M7 (control), was rigorously designed. At 12 months of p-HGNS therapy, the treatment arm responder rate was 65%, with responders defined as those who saw at least a 50% improvement from the baseline AHI and an AHI value below 20.

The median AHI in the p-HGNS treatment group was 34.3 e/hr at baseline and 11.6 e/hr at M7; the difference in median (95% confidence interval) AHI between the treatment and control groups at M7 was −18.9 (−27.0, −10.6) e/hr. By M13, outcomes improved in both groups; median AHI in the p-HGNS treatment group was 11.0 e/hr with treatment and 20.9 e/hr in the control group (now active).

“FDA approval of the aura6000 System 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,” 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.”

Check out MPO’s recent interview with LivaNova CEO Vladimir Makatsaria!