Video: FDA Approves Hologic's Adiana(R) Permanent Contraception System
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Adiana system offers safe, simple, effective alternative to tubal ligation
BEDFORD, Mass., July 7 /PRNewswire-FirstCall/ -- Hologic, Inc., (Hologic or
the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of
premium diagnostics, medical imaging systems and surgical products dedicated
to serving the healthcare needs of women, today announced the U.S. Food and
Drug Administration (FDA) has approved the Company's premarket approval (PMA)
application for the Adiana(R) permanent contraception system. The Adiana
system is designed to provide women a minimally-invasive, non-incision
alternative to traditional, surgical means of permanent contraception. In
January 2009, Hologic received CE marking approval for the Adiana system and
commenced marketing and sales of this product in certain European countries.
In addition to this News Release, please view the Multimedia News Release
related to the Adiana system at: http://www.prnewswire.com/mnr/adiana/38601.
To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/adiana/38601/
The Adiana permanent contraception procedure is minimally invasive, requires
no incisions and can be performed in the comfort of the doctor's office using
local anesthesia. Patients are normally able to return to work or resume their
daily activities within one day. In contrast, traditional methods of permanent
contraception, such as tubal ligation, require more invasive surgical
procedures, usually are conducted in a hospital under general anesthesia and
typically require four to five days of recovery. As a result, these more
invasive surgical procedures can pose serious risk of complications, including
anesthesia-related problems and damage to organs or blood vessels. There were
approximately 70,000 female transcervical contraception procedures performed
in the U.S. last year.(1)
"While tubal ligation is the most common form of permanent contraception used
throughout the world, hysteroscopic procedures such as those employing the
Adiana permanent contraception system enable women to choose lifetime
protection from pregnancy without the risks of general anesthesia and the
longer recovery periods associated with traditional sterilization procedures,"
said Ted Anderson, M.D., Ph.D., associate professor of obstetrics and
gynecology at Vanderbilt University, and clinical investigator of the pivotal
clinical trial for the Adiana system. "The Adiana procedure is a safe and
simple alternative that not only provides patients with peace of mind in
preventing pregnancy, but also leaves nothing in the uterus that might limit
women's options for future gynecologic tests and procedures."
The Adiana procedure is indicated for women who desire permanent birth control
by occlusion of the fallopian tubes. Ideal candidates include women who do not
want children in the future and would like the peace of mind and convenience
of permanent birth control. The procedure may also be an ideal solution for
women who desire permanent birth control but are poor candidates for surgery.
"Many women seek relief from the uncertainty and hassle of temporary birth
control methods once they know their childbearing is complete. However, few
know that permanent contraception is available without incisions, the use of
general anesthesia, or need for lengthy hospital stays," said Tony Kingsley,
senior vice president, GYN surgical products at Hologic. "With the Adiana
permanent contraception system, we are very excited to be able to offer these
women a new alternative for their long-term contraception needs."
During the Adiana procedure, a slender, flexible instrument is passed through
the body's natural openings to deliver a low level of radiofrequency (RF)
energy to a small section of each fallopian tube. A tiny, soft insert, about
the size of a grain of rice, is then placed in each fallopian tube in the
location where the energy was applied. During the three months following the
procedure, the patient continues to use temporary birth control while new
tissue grows in and around the Adiana inserts, eventually blocking the
fallopian tubes. At three months, a special x-ray test (called a
hysterosalpingogram or HSG) is performed to confirm the fallopian tubes are
completely blocked and the patient may begin relying on Adiana for permanent
contraception.
"This is another significant milestone for Hologic and our GYN surgical
products business," said Tony Kingsley. "With FDA approval of the Adiana
system, we are now able to provide physicians with another non-hormone,
minimally-invasive therapy that addresses a significant issue for women in
their post-childbearing years."
(1) January 2009, "U.S. Markets for Women's Health Devices," iData Research,
Vancouver, British Columbia, Canada. iData is an international market research
and consulting group.
About Hologic, Inc.
Hologic, Inc. is a leading developer, manufacturer and supplier of premium
diagnostics products, medical imaging systems and surgical products dedicated
to serving the healthcare needs of women. Hologic's core business units are
focused on breast health, diagnostics, GYN surgical, and skeletal health.
Hologic provides a comprehensive suite of technologies with products for
mammography and breast biopsy, radiation treatment for early-stage breast
cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis
assessment, preterm birth risk assessment, mini C-arm for extremity imaging
and molecular diagnostic products including HPV and reagents for a variety of
DNA and RNA analysis applications. For more information, visit
www.hologic.com.
Forward Looking Statement Disclaimer
This News Release may contain forward-looking information that involves risks
and uncertainties, including statements about the effect and adoption of the
use of the Adiana system. There can be no assurance that the system will
achieve the benefits described herein and that such benefits will be
replicated in any particular manner with respect to an individual patient as
the actual effect of the use of the Adiana system can only be determined on a
case-by-case basis depending on the particular circumstances of the procedure
and patient in question. Thus there can be no assurance of general adoption of
this technology by the medical community. Hologic expressly disclaims any
obligation or undertaking to release publicly any updates or revisions to the
data or statements presented herein to reflect any change in the Company's
expectations or any change in events, conditions or circumstances on which any
such data or statements are based. Certain factors that could adversely affect
the Company's business and prospects are described in Hologic filings with the
Securities and Exchange Commission.
Hologic and Adiana are trademarks and/or registered trademarks of Hologic,
Inc., and/or its subsidiaries in the United States and/or other countries.
Contact: For Investors: For Media:
Deborah R. Gordon Stephanie Cilibrasi
Vice President, Associate Product Manager, Adiana
Investor Relations Hologic, Inc.
Hologic, Inc. (508) 263-8974
(781) 999-7716 adianamedia@hologic.com
SOURCE Hologic, Inc.
Investors: Deborah R. Gordon, Vice President, Investor Relations,
+1-781-999-7716, or Media: Stephanie Cilibrasi, Associate Product Manager,
Adiana, +1-508-263-8974, adianamedia@hologic.com, both of Hologic, Inc.
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