FDA Approves Endometrial Ablation System for Treatment of Menorrhagia
By Laurie Barclay, MD
Medscape Medical News
May 25, 2010 — The US Food and Drug Administration (FDA) has approved a new endometrial ablation system (Genesys HTA System; Boston Scientific) for the treatment of menorrhagia, which affects approximately 10 million women in the United States. This next-generation endometrial ablation system is intended for premenopausal women with menorrhagia.
CE Mark approval, which is a European Union certification of product safety, was granted in January.
Compared with the manufacturer's current endometrial ablation system, the new system has a smaller and lighter console and simplified set-up requirements. It also has an enhanced graphic user interface for step-by-step guidance through endometrial ablation. Several technology upgrades are intended to improve operating performance.
"The new Genesys HTA System has streamlined the procedure set-up and provides my patients an effective means to address their menorrhagia," said Christopher Guyer, MB, BS, MRCOG, a gynecologist from Queen Alexandra Hospital in Portsmouth, United Kingdom.
