Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement

"Timeline of Visits~* Screening~* Baseline: Official baseline, assessment primary \& secondary objectives~* Implantation of device~* Activation \& fitting: Baseline active device; implanted device has just been activated; assessment of secondary objectives only~* 8 FU Visits over 2 years after activation; Includes~ * Baseline Switch Off: results of the visit preceding a 14-day switch-off of the device; assessment of secondary objectives only~ * Endpoints for~ * Pivotal phase: 12 months after activation; official endpoint for assessment of primary \& secondary objectives~ * Active post-pivotal phase: 24-month follow-up; endpoint for all secondary objectives~ * Switch Off: 2 Visits; assessment of secondary objectives only~ * Repeated checkpoints to assess device effects over 2 years: 5 visits; assessment of secondary objectives only Device shall increase respiratory patency during inspiration, assessed by normalized PIF; other outcome measures are used to assess secondary objectives"