Conceptus(R) Achieves New Milestone as FDA Approves 10-Year Commercial Data for Essure(R) Label
April 11 2012 - 9:00AM
Conceptus, Inc. (Nasdaq:CPTS), developer of the
Essure® procedure, the leading non-surgical permanent birth control
method, announced today that the U.S. Food and Drug Administration
(FDA) has approved inclusion of 10 years of data on Essure
effectiveness in commercial settings in the Essure procedure U.S.
Instructions for Use (IFU) and Patient Information Booklet (PIB).
In addition, the FDA has approved inclusion of the full five-year
clinical study results and effectiveness rate of 99.83% in the IFU
and PIB, which brings to a close the Essure clinical trials that
began in 1998. The Essure procedure has maintained its
unprecedented record of zero pregnancies among clinical trial
subjects over five years.
During the 10-plus years that Essure has been available
commercially worldwide, Conceptus has collected records of all
reported pregnancies from commercial use of the Essure procedure
and their causes. Based on these reports, the Essure
procedure's 10-year commercial pregnancy experience tracks closely
with its new five-year clinical rate of 99.83%. Pregnancies that
occurred in commercial use primarily stemmed from patient
non-compliance or misinterpreted confirmation tests.
"Our Essure commercial experience data and new five-year
clinical efficacy rate represent additional positive developments
in Essure's decade of use. Along with a successful 10-year
track record, Essure offers key advantages to multiple
audiences. More than two-thirds of Essure procedures in the
U.S. are performed in a physician's office, resulting in greater
safety and convenience for patients, increased operating efficiency
for physicians and cost savings for payors," said D. Keith
Grossman, president and chief executive officer of
Conceptus. "These milestone data points support our continuing
efforts to define the Essure procedure as the best choice for
permanent birth control for patients, physicians and
providers."
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the first
permanent birth control method that can be performed in the comfort
of a physician's office in less than 10 minutes (average
hysteroscopic time) without hormones, cutting, burning or the risks
associated with general anesthesia or tubal ligation. Soft,
flexible inserts are placed in a woman's fallopian tubes through
the cervix without incisions. Over the next three months, the body
forms a natural barrier around and through the inserts to prevent
sperm from reaching the egg. Three months after the Essure
procedure, a doctor is able to perform an Essure Confirmation Test
to confirm that the inserts are properly placed and that the
fallopian tubes are fully blocked, allowing the patient to rely
upon Essure for permanent birth control.
The Essure procedure is 99.83% effective based on five years of
follow up with zero pregnancies reported in clinical trials, making
it the most effective form of permanent birth control on the
market. Essure's 10-year commercial data tracks closely with
its five-year clinical results, and Essure has been proven and
trusted by physicians since 2002. The Essure procedure is
covered in the U.S. by most public and private insurance plans and
more than 600,000 women worldwide have undergone the
procedure.
About Conceptus®, Inc.
Conceptus, Inc. is a leader in the design, development and
marketing of innovative solutions in women's healthcare. The
Company manufactures and markets the Essure procedure. The
Essure procedure is available in the United States, Europe,
Australia, New Zealand, Canada, Mexico, Central and South America
and the Middle East.
The Conceptus, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Please visit www.essure.com for more information on the Essure
procedure. Patients may call the Essure Information Center at
1-877-ESSURE-1 with questions or to find a physician in their
area.
© 2012 Conceptus, Inc.— All rights reserved.
CC-3096 10APR12F
CONTACT: Investor and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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