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FDA Clears Interlace Medical’s MyoSure™ Hysteroscopic Tissue Removal System for The Treatment of
Submucosal Fibroids
Framingham Mass., October 28th, 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". “In addition, the MyoSure
device’s small outer diameter minimizes the need for cervical
dilation often associated with other hysteroscopic procedures
thereby reducing cervical perforation and trauma.”, said Bill
Gruber, President and CEO of Interlace medical.
“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.
For additional information visit
www.interlacemedical.com or
contact:
Bill Gruber
President and CEO
Interlace Medical
508-875-1343
bill @interlaceMedical.com
Nicole M. Shugrue
Director of Marketing
Interlace Medical
508-875-1343
nicole @interlacemedical.com
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