New data from LivaNova has demonstrated the clinical benefit of its programming algorithm in patients with obstructive sleep apnoea (OSA).
Trial data demonstrated that the company’s PolySync programming algorithm increased the response rate for OSA patients undergoing proximal hypoglossal nerve stimulation (p-HGNS) treatment to 84.5%. Stimulation was administered via the aura6000 system, also developed by LivaNova.
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P-HGNS is a neuromodulation modality within aura6000 that works via a pulse generator implanted under the skin near the clavicle on the trunk of the hypoglossal nerve, which is responsible for controlling the muscles in the tongue. Meanwhile, the company’s PolySync programming algorithm is designed to expand the variety and number of possible p-HGNS stimulation fields in patients undergoing OSA treatment with aura6000.
LivaNova’s aura6000 system obtained premarket approval (PMA) from the US Food and Drug Administration (FDA) in March 2026, with the company previously outlining its expectations for an anticipated US market launch in 2027.
The company’s device works by delivering synchronised electrical pulses to the hypoglossal nerve, causing the tongue to move forward and stiffen, thereby preventing airway collapse during sleep.
The PolySync findings were from the OSPREY (NCT04950894) randomised control trial (RCT). In initial data shared in May 2025, the treatment arm responder rate was 65% after 12 months of therapy. Responders were defined as those who realised at least a 50% improvement from the baseline (AHI) and an AHI value below 20.
In the PolySync sub-study, patients who did not meet responder criteria after one year of individual-contact stimulation instead underwent reprogramming using simultaneous-contact stimulation (a different programming strategy configured with PolySync). This approach converted the majority of these patients into responders, increasing the cumulative response rate to 84.5%.
The latest results were shared at the American Academy of Sleep Medicine’s (AASM) SLEEP 2026 annual meeting, taking place in Baltimore, Maryland, between 14-17 June.
According to LivaNova, the new findings indicate that PolySync holds the potential to allow for “broader and more flexible activation” of the tongue muscles to improve the responsiveness of p-HGNS therapy with the British company’s system.
LivaNova’s chief innovation officer, Ahmet Tezel, commented: “These results underscore the strength of our underlying therapy and the opportunity to further enhance outcomes through innovation.
“OSPREY demonstrated rapid and durable clinical benefit, and PolySync shows that we can meaningfully build on that foundation by improving response rates and expanding the impact of p-HGNS therapy.”
LivaNova’s system is suitable for use in patients with an apnoea-hypopnea index (AHI) (a scale to measure sleep apnoea severity) between 15 and 65, who have either not succeeded or proven ineligible for first-line OSA treatment therapies such as controlled positive airway pressure (CPAP).
