Table 5.
Outcomes of the Full and US-only Cohorts of the SONATA Pivotal IDE Trial
| Parameter | SONATA (US+Mexico) | SONATA (US) |
|---|---|---|
| ≥ 50% reduction in menstrual bleeding at 12 months (%) | 64.8 (N=142) | 65.3 (N=121) |
| Freedom from surgical reintervention at 12 months (%) | 99.3 (N=143) | 99.2 (N=122) |
| Mean SSS reduction at 12 months (points) | 32.1 (N=135) | 33.8 (N=115) |
| Mean HRQOL increase at 12 months (points) | 43.7 (N=134) | 45.8 (N=115) |
| Percentage of patients reporting improvement in overall fibroid symptoms (OTE questionnaire) | 96.3 (N=135) | 97.4 (N=115) |
| Mean return to normal daily activities (days) | 2.2 (N=139) | 2.1 (N=118) |
| Mean return to work (days) | 3.6 (N=111) | 3.7 (N=96) |
| Mean length of stay (hours) | 2.5 (N=147) | 2.5 (N=125) |
| Percentage of patients at least “Somewhat Satisfied” at 12 months | 97.1 (N=135) | 98.3 (N=115) |
| Percentage of patients who would at least “Probably Recommend” Sonata to a friend or family member | 97.1 (N=135) | 96.5 (N=115) |