Interlace Medical receives 510K clearance to market MyoSure Hysteroscopic Tissue Removal System

Oct 28 2009

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 .