MARLBOROUGH, Mass.,
Feb. 2, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) today announced the launch of
its next-generation NovaSure® ADVANCED global
endometrial ablation (GEA) system in the
United States. The system has been FDA approved.
The NovaSure system is designed to reduce abnormal uterine
bleeding (AUB) by applying radiofrequency energy to the
endometrium, gently ablating the lining of the uterus in two
minutes or less.1 The NovaSure ADVANCED device offers a
slimmer 6 mm diameter designed to improve patient comfort and
physician ease-of-use while maintaining the clinical efficacy of
the trusted NovaSure system.
The NovaSure ADVANCED device has a smaller sheath size requiring
less cervical dilation than the 8 mm NovaSure device, which is the
current standard of care. By minimizing the dilation required,
physicians can reduce patient discomfort when performing the
NovaSure procedure in an office setting.
The updated device is also equipped with an acorn-like shaped
cervical seal that creates an increased sealing surface within the
cervical canal and provides 13% more "working length" than the
previous device.2 Additional enhancements include
rounded Smooth Access™ tips to simplify insertion† and a
blue handle that serves as a useful reminder for how the device
should be inserted.
The NovaSure ADVANCED system launched in Europe, Canada and Australia in 2016.
"I have relied on the NovaSure system for years and it has
proven superior to other endometrial ablation modalities, offering
a safe, effective and rapid treatment to heavy menstrual bleeding,"
said Dr. Francis Gardner, Consultant
Gynaecologist at the Queen Alexandra Hospital in Portsmouth, England. "The introduction of the
NovaSure ADVANCED system is a significant advancement. In
addition to providing a more comfortable experience for patients
due to the smaller diameter, physicians, like myself, will be able
to perform more procedures in office, while maintaining the same
efficacy of the trusted NovaSure system."
Abnormal uterine bleeding is a condition that affects one in
five women and can be lifestyle-restricting.3 NovaSure
endometrial ablation is a one-time procedure that can be performed
either in the doctor's office or the operating room. The procedure
is safe and effective, dramatically reducing or stopping menstrual
bleeding in 90% of women.4 More than 2.5 million women
have chosen the NovaSure procedure to treat abnormal uterine
bleeding.2
"The next-generation NovaSure ADVANCED system promises the same
efficacy and safety profile that physicians have trusted for more
than 10 years," said Dr. Edward
Evantash, Medical Director, Hologic. "As a part of our
ongoing commitment to our customers, we evolved the NovaSure system
to provide the enhancements our customers requested to improve
physician ease-of-use and ensure an optimal patient
experience."
For more information on NovaSure ADVANCED, visit
www.novasure.com/ADVANCED.
About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier
of premium diagnostic products, medical imaging systems and
surgical products. The Company's core business units focus on
diagnostics, breast health, GYN surgical and skeletal health. With
a unified suite of technologies and a robust research and
development program, Hologic is dedicated to The Science of Sure.
For more information on Hologic, visit www.hologic.com.
Hologic, NovaSure, Smooth Access, The Science of Sure, and
associated logos are trademarks and/or registered trademarks of
Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All
other trademarks, registered trademarks, and product names are the
property of their respective owners.
Forward-Looking Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic products. There can be no assurance these products
will achieve the benefits described herein or 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 products
can only be determined on a case-by-case basis. In addition, there
can be no assurance that these products will be commercially
successful or achieve any expected level of sales. Hologic
expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any such statements presented
herein to reflect any change in expectations or any change in
events, conditions or circumstances on which any such data or
statements are based.
This information is not intended as a product solicitation or
promotion where such activities are prohibited. For specific
information on what products are available for sale in a particular
country, please contact a local Hologic sales representative or
write to womenshealth@hologic.com.
Media Contact:
Jane
Mazur
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact:
Michael
Watts
858.410.8588
michael.watts@hologic.com
References
- NovaSure Instructions for Use
- Hologic Inc., Data on file, 2016
- Centers for Disease Control and Prevention. Blood disorders in
women: heavy menstrual bleeding.
http://www.cdc.gov/ncbddd/blooddisorders/women/menorrhagia.html.
Accessed September 24, 2015
- Cooper J, Gimpleson R, Laberge P, et al. A randomized,
multicenter trial of safety and efficacy of the NovaSure system in
the treatment of menorrhagia. J Am Assoc Gynecol Laparosc.
2002;9(4):418-428
† Based on internal bench testing that measured
perceived ease of insertion through a simulated cervix of both the
6-mm and 8-mm devices. N=16 surgeon users
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SOURCE Hologic, Inc.