Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) approval of its Genesys HTA™ System for the treatment of menorrhagia. The Genesys HTA System is a next-generation endometrial ablation system designed to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia.
Menorrhagia is abnormally heavy and prolonged menstrual bleeding. An estimated 10 million women in the U.S. suffer from this condition.
The Genesys HTA System represents a significant advance in Boston Scientific's endometrial ablation technology. It features a smaller and lighter console, simplified set-up requirements, and an enhanced graphic user interface which offers step-by-step guidance through the procedure. The System also incorporates several technology upgrades designed to improve operating performance while delivering the same proven clinical therapy of the Company's current HTA Endometrial Ablation System.
"FDA approval of the Genesys HTA System is the latest example of our commitment to developing products in the Women's Health arena that improve patients' lives," said John Pedersen, Senior Vice President and President of Boston Scientific's Urology and Women's Health Division. "We are pleased we will be able to offer this next-generation system to U.S. patients suffering from menorrhagia."
The System received CE Mark approval in January.
"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, M.B., B.S., M.R.C.O.G., a gynecologist at Queen Alexandra Hospital, Portsmouth, U.K.
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