LivaNova Reports 11% Q1 Growth as FDA PMA and New Data Propel Sleep Apnea Push
Management plans a 2027 launch for its aura6000 implant.
Overview
- LivaNova said Q1 2026 revenue rose 11% on broad strength, with cardiopulmonary and epilepsy driving gains.
- The cardiopulmonary segment delivered $209 million in revenue, up 14% from a year earlier.
- The company secured FDA premarket approval in March for aura6000, a hypoglossal nerve stimulation implant for adults with moderate to severe obstructive sleep apnea.
- Leaders highlighted that aura6000 was approved without a complete concent to collapse contraindication or warning, and 12-month OSPREY trial results in Annals of Internal Medicine showed sustained, clinically meaningful improvements.
- Executives outlined a planned market entry next year, citing up to 1 million annual CPAP dropouts with less than 5% alternative therapy use, while noting current HGNS reimbursement uncertainty as temporary and continuing Essenz rollouts and oxygenator capacity work.