A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding

Inclusion Criteria:

- 25 to 50 years of age;

- PBLAC score of 150 or greater;

- Completed child-bearing;

- Normal Pap smear within 12 months;

- Cervix suitable for tenaculum placement as determined by pelvic exam;

- At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology
(e.g., as opposed to adenomyosis) of fibroids determined through ultrasound;

- Willing to maintain use or non-use of hormonal contraception from 3 months pre-study
throughout the 12-month follow-up period;

- Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months
pre-study throughout the 12-month follow-up period;

- Able to tolerate the required prolonged supine position during treatment
(approximately 6 hours);

- Willing and able to provide informed consent and to follow study-related
requirements;

Exclusion Criteria:

- Pregnancy (as confirmed immediately prior to procedure)

- Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; [or
if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3
dimensions (length, height, width) are measured, total dimension greater than 24 cm];

- Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline
infused sonography;

- Hydronephrosis as determined by radiologist interpretation on renal ultrasound
pre-procedurally;

- Menopausal;

- Clinical history of any thromboembolic disease;

- Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than
1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine
segment fibroids determined through pelvic exam;

- History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic
inflammatory disease;

- Abnormal endometrial biopsy within the last 6 months prior to procedure;

- Pelvic mass outside the uterus suggesting other disease processes;

- Any current acute or chronic systemic infection or localized pelvic infection,
including an unresolved urinary tract infection;

- Using GnRH agonist or mifepristone within 6-months prior to the start of the study;

- An intrauterine device (IUD) in place;

- Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an
underlying bleeding disorder;

- Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation
(e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices);

- Prior endometrial ablation, uterine artery embolization, or uterine artery ligation;

- Poor procedural candidate due to medical conditions as determined by the investigator
(e.g. anesthesia class, renal insufficiency, heart disease);

- Grade 1 for 3D Color Doppler or no flow observed for cystoscopy on ureter flow
assessment if applicable.