Improvements designed to increase ease of use especially in the office
MOUNTAIN VIEW, Calif., Nov. 30 /CNW/ -- Conceptus, Inc. (Nasdaq: CPTS)
today announced the approval of its third generation Essure(R) permanent birth
control system by Health Canada. System modifications include changes to the
delivery system that reduce the number of steps a physician is required to
perform during a placement procedure.
In addition to the enhanced ease-of-use, hysteroscopic visualization of
the implant and placement markers was significantly improved. A new
DryFlow(TM) Introducer, which alleviates distension fluid loss, a major safety
concern of hysteroscopists, is packaged with the product.
"These modifications, which were made in response to physician
recommendations, were approved by the U.S. Food and Drug Administration this
past summer allows them to more easily add the Essure procedure to their
practice services," said Mark Sieczkarek, president and chief executive
officer of Conceptus, Inc., developer of the Essure procedure. "We anticipate
that the physician response in Canada will be similar and will foster wider
physician adoption, giving more women opportunity to select permanent birth
control without the need to undergo tubal ligation and the risks associated
"Canadian women who have decided that their family is complete, now have
an even more advanced method of permanent birth control without surgery,"
Robert Sabbah, MD, chief of gynecology at Sacre Coeur hospital in Montreal and
assistant professor of obstetrics and gynecology at the University of
Montreal. "We are looking forward to offering this non-incisional procedure
to our patients seeking permanent birth control."
The Essure procedure remains the first and only female sterilization
procedure to have zero pregnancies in the clinical trials. It is approved for
sale in Canada, the United States, Mexico, Central and South America, New
Zealand, Australia and Europe. To date, more than 150,000 Essure procedures
have been performed worldwide.
In previous clinical studies, Essure patients experienced little
discomfort, returned to normal activity sooner and expressed a greater level
of overall satisfaction when compared to tubal ligation. Because the Essure
procedure does not require incisions, it can be performed in the comfort of a
physician's office in less than 15 minutes with a local anesthetic. Most
women who get the Essure procedure are able to return to work or other
activities the following day. It is also the only female birth control method
that uses a test to confirm protection from pregnancy, providing women with
peace of mind.
About the Essure Procedure
The Essure procedure, initially approved by Health Canada in 2001 and by
the U.S. FDA in 2002, is a permanent birth control procedure that replaces
tubal ligation for women. In the comfort of a physician's office and in less
then 15 minutes, the soft micro-inserts are placed into the Fallopian tubes
through the cervix eliminating the need for incisions. Once in place, the
device is designed to elicit tissue growth in and around the micro-insert to
form an occlusion or blockage in the Fallopian tubes.
The Essure confirmation test is performed three months after the
procedure to confirm that the micro-inserts are in the correct location, the
tubes are blocked and that the woman can discontinue temporary birth control.
The Essure procedure is 99.80% effective with four years of data and is the
first and only FDA approved female sterilization procedure to have zero
pregnancies in clinical trials.
Conceptus, Inc. manufactures and markets the Essure Permanent Birth
Control system, an innovative medical device and procedure designed to provide
a non-incisional alternative to tubal ligation, which is currently the leading
form of birth control worldwide. The availability of the Essure procedure in
the U.S. is expected to open up a market currently occupied by incisional
tubal ligation and vasectomy, which combined account for over 1 million
Additional information about the Essure procedure is available at
http://www.essure.com or by calling the Essure Information Center at
1-877-ESSURE1. Additional information about Conceptus is available at
http://www.conceptus.com or by calling 1-877-ESSURE2.
For further information:
For further information: Corporate, Debbie Donovan of Conceptus,
+1-650-962-4118, firstname.lastname@example.org; or Media, Kristen Sargent of
FischerHealth, +1-310-577-7870, ext.125, email@example.com; or
Investor Relations, Kim Sutton Golodetz of Lippert-Heilshorn & Associates,
+1-212-838-3777, firstname.lastname@example.org, both for Conceptus, Inc. Web Site: