FDA approves uterine artery embolization beads. (Symptomatic Uterine Fibroids).

The use of miniature acrylic copolymer beads in uterine artery embolization has been approved by the Food and Drug Administration for treating symptomatic uterine fibroids.

The material, Embosphere Microspheres, manufactured by Biosphere Medical is "the first embolic agent to be cleared specifically for uterine fibroid embolization," (UAE) although embolization procedures have been performed for more than 25 years, the Food and Drug Administration said in a statement announcing the approval. The material was approved in 2000 for treating arteriovenous malformations and hypervascular tumors.

This product and another product approved by the FDA for treating hypervascular tumors, polyvinyl alcohol particles, have been used off-label for uterine fibroids since they were approved for treating hypervascular tumors.

The approval and the study on which approval was based suggest "that this is a reasonable alternative to hysterectomy ... and [physicians] ought to consider this as an alternative for patients who do not choose to have a hysterectomy" said Dr. James Spies, who is on the medical advisory board of Biosphere and is an associate professor of radiology at Georgetown University Washington, D.C.

The UAE procedure entails inserting a catheter through the femoral artery and into the uterine artery where the round, hydrophilic beads are injected. These particles are carried to the fibroids and embolized "until there is subtotal occlusion of the uterine artery" Dr. Spies said.

The procedure takes about 1-1.5 hours and usually requires 1 day in the hospital.

Approval was based on a multicenter trial of 182 women with fibroids, data on UAE procedures in the medical literature, the FDA's adverse events reporting system, and a registry of ...