Conceptus(R) Receives FDA Approval for Compatible Use of Hologic's NovaSure(R) with Essure(R) Inserts in Place
February 29 2012 - 7:00AM
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) approved labeling changes pertaining to the use of bipolar
radio frequency (RF) NovaSure® Impedance Controlled Endometrial
Ablation System(1) following the placement of Essure inserts and a
successful Essure Confirmation Test. The expanded label change
followed the Company and the FDA reaching an agreement on the
post-approval study (PAS) protocol.
The Essure procedure is now approved to be safe and compatible
with all the major global endometrial ablation (GEA) technology
options that treat menorrhagia. The Essure procedure U.S.
Instructions for Use (IFU) will add NovaSure®(1) to its existing
list of compatible GEA procedures that includes GYNECARE
THERMACHOICE® Uterine Balloon Therapy System(2) and Hydro
ThermAblator® System(3). Pregnancy following ablation can be
dangerous for both mother and fetus, therefore effective permanent
birth control is a vital solution for patients preparing to undergo
a GEA procedure.
"This important FDA approval effectively removes a major barrier
for physicians to use the NovaSure procedure with the
market-leading Essure, the most effective form of permanent birth
control. The positive change also builds upon our win last
year when the FDA approved the removal of the nickel
hypersensitivity contraindication from our IFU," said Keith
Grossman, president and chief executive officer of Conceptus.
"Our competitive advantage and leadership in the permanent birth
control market has been significantly strengthened by this upgraded
label," added Mr. Grossman. "We will be communicating the change to
the OB/GYN community, and especially to those physicians who have
used the competitor's hysteroscopic sterilization product with
NovaSure."
(1) Registered trademark of Hologic, Inc.
(2) Registered trademark of ETHICON™ Women's Health
& Urology, a division of Ethicon, Inc.
(3) Registered trademark of Boston Scientific
Corporation
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 public and private
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 more than
600,000 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.
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.
The Conceptus, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, the accuracy of which is subject to known and unknown
risks and uncertainties. These forward-looking statements include,
without limitation, discussions regarding expected benefits from
FDA-approved changes to the Essure procedure U.S. Instructions for
Use (IFU) that expands Essure indications for use, our competitive
positioning as a result of the expanded Essure procedure U.S. IFU
label, our ability to market effectively to physicians and
prospective patients, and the expected attainment of strategic
initiatives intended to grow the business. These discussions
and other forward-looking statements included herein may differ
significantly from actual results. Such differences may be based
upon factors such as changes in strategic planning decisions by
management, re-allocation of internal resources, changes in the
impact of domestic and global macroeconomic pressures,
reimbursement decisions by insurance companies and domestic and
foreign governments, scientific advances by third parties,
litigation risks, attempts to amend or repeal all or part of the
Patient Protection and Affordable Care Act of 2010 as amended, and
the introduction of competitive products, as well as those factors
set forth in the Company's most recent Annual Report on Form 10-K
and most recent Quarterly Report on Form 10-Q, and other filings
with the Securities and Exchange Commission. These
forward-looking statements speak only as to the date on which the
statements were made. We undertake no obligation to update or
revise publicly any forward-looking statements, whether as a result
of new information, future events, or otherwise.
© 2012 Conceptus, Inc.— All rights reserved.
CC-3015 28FEB12F
CONTACT: Investor and Public Relations Contact:
Cindy Klimstra
(650) 962-4032
cindy_klimstra@conceptus.com
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