Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization Compared to Embosphere for Symptomatic Relief From Uterine Fibroids

Inclusion Criteria:

- Subject is able to provide informed consent and must sign the Institutional Review
Board approved Informed Consent Form.

- Pre-menopausal women age 30-50 years at time of enrollment

- Have been selected forUterine Fibroid Embolization (UFE) prior to entry to the study.

Exclusion Criteria:

- Patient has a history of pelvic malignancy

- Patient has an abnormal Pap smear within 12 months of the planned Uterine Fibroid
Embolization procedure

- Patient with coexisting condition that might explain abnormal bleeding (including
endometrial hyperplasia and adenomyosis) or pelvic pain (including endometriosis and
ovarian cysts).

- Is at substantial risk for the need of organ transplantation, such as renal
insufficiency.

- Patient has evidence of current or recent pelvic inflammatory disease or uterine
infection.

- Patient with a severe contrast allergy or renal insufficiency that would represent a
contradiction to the administration of iodine-based contrast agents.

- Patients unable to comply with the follow-up requirements of the study.