Merit Medical Systems, Inc.
This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
Inclusion Criteria: * Adult women ≥ 18 years old at the time of enrollment. * Subject has symptomatic uterine fibroid(s), suitable to embolization. * Subject provides written informed consent. Exclusion Criteria: * Subject is pregnant. * Subject has suspected pelvic inflammatory disease or any other pelvic infection. * Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
Bearing nsPVA Embolization Particles are irregularly-shaped, biocompatible, hydrophilic, nonresorbable particles produced from polyvinyl alcohol. These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon selective placement through a variety of catheters. Bearing nsPVA Embolization Particles are used for the embolization of symptomatic (leiomyoma uteri) uterine fibroids.
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