FDA核准子宮內膜剝除系統用於痛經治療

作者：Laurie Barclay, MD  
出處：WebMD醫學新聞

　　May 25, 2010 — 美國食品藥物管理局（FDA）核准了一種新的子宮內膜剝除系統（Genesys HTA系統；波士頓科技公司）用於治療痛經；在美國，這大概影響了1000萬位女性；這個次世代的子宮內膜剝除系統適用於停經前且有痛經的婦女。
　　
　　CE Mark於一月同意這個系統上市，這是歐盟產品的安全認證。
　　
　　相較於目前的子宮內膜摘除系統，這個新系統操作裝置較小、較輕且設備簡單；這個系統也有依步驟指引子宮內膜剝除的圖形介面。為了提高操作效率，許多科技都已經更新。
　　
　　英國Portsmouth Queen Alexandra醫院婦產科醫師Christopher Guyer表示，新的Genesys HTA系統已針對設立步驟提升效率，提供了病患一個有效處理其痛經問題的方法。


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.