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Devices FDA

 News Release - October 28, 2009

FDA Clears Interlace Medical's MyoSure(TM) Hysteroscopic Tissue Removal System for The Treatment of Submucosal Fibroids

FRAMINGHAM, Mass., Oct., 28--(HSMN NewsFeed)--Interlace Medical, Inc., today announced that it has received 510K clearance from the U. S. Food and Drug Administration (FDA) to market the MyoSure Hysteroscopic Tissue Removal System for the removal of submucosal fibroids and polyps.

The MyoSure System enables physicians to quickly remove fibroids in a single step, avoid risks associated with energy-based devices, and will provide women with an incision-less treatment alternative that preserves uterine form and function. The easy-to-use device provides gynecologists with confidence, control and a minimally invasive care option for their patients.

"An increasing number of gynecologists and their patients are choosing less invasive treatment options which preserve uterine form and function and fewer life interruptions. With the MyoSure System, a 3cm fibroid (about the size of a walnut) can be removed in less than 10 minutes,” said Bill Gruber, President and CEO of Interlace medical. “In addition, the MyoSure device’s small outer diameter minimizes the need for cervical dilation often associated with other hysteroscopic procedures thereby reducing the risk of cervical perforation and trauma.”

“The availability of the MyoSure System allows me to offer a clinically effective front line solution vs. traditional drug therapy which has proven to be ineffective in the treatment of my symptomatic patients”, said Kelly Roy, M.D. of Phoenix Gynecology Consultants, Phoenix, AZ .

About Fibroids

Nearly 80% of all women will develop fibroids in their lifetime. The economic impact of fibroids is considerable. With an estimated 200,000 hospital admissions, costing more than $2 billion per year, fibroids clearly have a significant public health impact. These estimates do not include medical costs incurred in outpatient settings, or nonmedical costs such as time lost from work, according to data reported by the Agency for Healthcare Research and Quality. The need for better solutions that reduce the economic burden associated with treating and managing fibroids continues to increase. Hysteroscopic Myomectomy is recognized by the American Academy of Obstetricians and Gynecologists (ACOG), as a safe and effective treatment of Abnormal Uterine Bleed (AUB) caused by fibroids and polyps and is clinically proven to relieve AUB symptoms by greater than 90% with a less than 20% chance of recurrence at five years.

By developing cost effective, technologically advanced devices that improve patient care, reduce cost and provide procedural convenience to physicians, Interlace Medical addresses an ongoing need for safer, less invasive gynecology procedures.

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Source: Interlace Medical

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