Shots:
- Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance
- In the RCT (therapy start: M1 vs M7), M12 responder rate was 65% (≥50% AHI reduction & AHI <20); at M7, ≥25% ODI reduction was 69% vs 38%, with median ODI reduced from 35 to 13 events (e)/hr. & AHI from 34.3 to 11.6 e/hr. (AHI diff.: −18.9 vs control); at M13, AHI was 11 vs 20.9 e/hr.; results were consistent across high-risk CCC subgroups
- LivaNova is also preparing a next-gen OSA device for a PMA supplement application, featuring MRI compatibility, secure & remote configuration, with a rechargeable battery. If approved, the device is expected to launch in the H1’27
Ref: Businesswire | Image: LivaNova| Press Release
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