Table 1.
Patient and Ablated Fibroid Characteristics
| Women (n) | 28 |
| Age at the beginning of each post-TFA pregnancy (years)a | |
| Mean ± SD | 35.6 ± 5.0 |
| Median (range) | 37 (22, 45) |
| Graviditya,b | |
| Mean ± SD | 1.5 ± 1.3 |
| Median (range) | 1 (0, 5) |
| Paritya,b | |
| Mean ± SD | 0.5 ± 0.7 |
| Median (range) | 0 (0, 2) |
| Nulligravidae (n)a | 9 |
| Clinical trial patients (n) | 9 |
| FAST-EU | 1 |
| SONATA | 2 |
| SAGE | 6 |
| Patients treated postmarket (n) | 19 |
| Total no. of fibroids ablated (n)a | 35 |
| Ablated fibroid diameter (cm)a | |
| Mean | 3.5 ± 1.7 |
| Median (range) | 3.1 (1, 7) |
| No. of fibroids ablated/patienta | |
| Mean | 1.4 ± 1.1 |
| Median (range) | 1 (1, 6) |
| Ablated fibroid FIGO type, n (%)a | |
| Type 1 | 1 (2.9) |
| Type 2 | 5 (14.3) |
| Type 3 | 3 (8.6) |
| Type 4 | 8 (22.9) |
| Type 5 | 2 (5.7) |
| Type 6 | 0 (0) |
| Type 2–5 | 16 (45.7) |
a
Exclusive of three women with ongoing pregnancies after postmarket use of the Sonata System whose consent for inclusion of their anonymous information is pending until their pregnancy outcomes have been realized (total number of post-TFA pregnancies = 36).
b
Gravidity and parity are all considered before each post-TFA pregnancy.
ART, assisted reproductive technology; FIGO, International Federation of Gynecology and Obstetrics; ICSI, intracytoplasmic sperm injection; IVF, in vitro fertilization; SD, standard deviation; TFA, transcervical fibroid ablation.