February 8, 2008, Newsletter Issue #271: Device to Treat Fibroids Wins Approval
Tip of the Week
The U.S. Food and Drug Administration has approved a medical device to shrink non-cancerous uterine fibroid tumors, sparing women from painful surgery to remove them.
The device, meant for women who no longer intend to become pregnant, could also save many from having to have hysterectomies, where the entire uterus is removed.
Made from a material called Embosphere Microspheres, the product is used in less invasive surgeries that involve uterine artery embolization (UAE), designed to block blood flow to the tumors and shrink them.
In clinical trials sponsored by the maker of the device, Biosphere Medical Inc., 132 women with uterine fibroids were treated at seven hospitals throughout the United States. After six months, 65 percent of women implanted had a 50 percent or more reduction in bleeding attributed to the fibroids.
As a condition of approval, the company is required to follow study participants for at least three more years to gauge the long-term effects of the treatment, including whether the fibroids tend to return, the FDA says.
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