LivaNova (LIVN) said new data showed its PolySync programming algorithm raised the cumulative response rate to 84.5% in moderate to severe obstructive sleep apnea patients by converting most non-responders after reprogramming.
The findings build on earlier results showing a 65% responder rate after 12 months of therapy delivered by the company's aura6000 system, LivaNova said Tuesday in a statement.
Reprogramming non-responders with simultaneous-contact stimulation significantly improved outcomes and produced no serious adverse events, the company said.
LivaNova plans to file a premarket approval supplement application with the US Food and Drug Administration in H2 for a next-generation device with MRI compatibility and other upgrades.
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