Conceptus(R) Receives FDA Approvable Letter for Compatible Use of Hologic's NovaSure(R) With Essure(R) Inserts in Place
November 08 2011 - 9:05AM
Conceptus, Inc. (Nasdaq:CPTS), developer of the
Essure® procedure, the most effective non-surgical permanent birth
control method available, announced today that it has received an
Approvable Letter from the U.S. Food and Drug Administration (FDA)
for labeling changes pertaining to the use of bipolar radio
frequency (RF) NovaSure Impedance Controlled Endometrial Ablation
following a successful Essure Confirmation Test.
In FDA's Approvable Letter, the agency stated that Conceptus'
PMA supplement is approvable subject to concurrence with a
post-approval study (PAS).
"Conceptus has worked diligently and collaboratively with the
agency to establish the safety of Essure when NovaSure RF
endometrial ablation is performed," said Mark Sieczkarek, president
and chief executive officer of Conceptus. "This labeling change
represents yet another choice for premenopausal women and their
physicians to consider while evaluating global endometrial ablation
(GEA) technology options to treat menorrhagia. We are pleased
with the FDA's decision and look forward to reaching agreement with
the agency on the PAS protocol and obtaining final approval of the
proposed labeling changes."
In July 2008, Conceptus received the CE Mark approval for
similar labeling changes related to the addition of GEA
technologies (i.e., NovaSure) that can be used safely and
effectively with Essure.
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 99.95% effective based on one year of
follow up with zero pregnancies reported in clinical trials, making
it the most effective form of permanent birth control on the
market. The procedure is covered by most insurance plans, and when
it is performed in a doctor's office the cost to the patient may be
as low as a simple co-pay. Essure has been proven and trusted by
physicians since 2002, with approximately 570,000 women worldwide
having undergone the Essure 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 Company also promotes the GYNECARE
THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's
Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN
physician offices.
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.
© 2011 Conceptus, Inc.—All rights reserved. Conceptus and Essure
are trademarks or registered trademarks of Conceptus, Inc.
CC-2954 7NOV11F
CONTACT: Investor Relations and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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