MARLBOROUGH, Mass.,
Nov. 1, 2017 /PRNewswire/ -- Hologic,
Inc. (Nasdaq: HOLX) announced today the U.S. launch of the
MyoSure® MANUAL device, which was designed to help
doctors more easily resect and remove intrauterine tissue in office
settings when used with the MyoSure hysteroscope.
The MyoSure MANUAL device joins the MyoSure suite of gynecologic
surgical products. The complete MyoSure system is a minimally
invasive hysteroscopic treatment for women with problematic tissue
that requires no cauterization, which preserves uterine form and
function. The system enables quick and convenient removal of
tissue, including a range of fibroids and polyps that may be the
root cause of Abnormal Uterine Bleeding (AUB), which affects up to
30% of pre-menopausal women.1
"We recognize the increased demand for in-office procedures, and
seek to develop innovative solutions to provide flexibility and
convenience for both physicians and patients," said Edward
Evantash, M.D., Medical Director and Vice President of Medical
Affairs, Hologic. "The MyoSure MANUAL device was designed for
in-office tissue removal procedures, requiring minimal setup and no
vacuum or fluid management system, while offering direct
visualization when used with the MyoSure hysteroscope."
The MyoSure MANUAL device has a fully integrated vacuum that
does not require external suction, and can be operated with a
one-liter saline bag. There is no need for a controller or
additional capital equipment for fluid management. The clear tissue
trap allows visual confirmation of tissue removed during the
procedure and holds up to 4g of tissue; it also detaches to send to
pathology. In addition, the MyoSure MANUAL device gives physicians
multi-function control of the 360° blade.
"The MyoSure MANUAL device is an exciting addition to Hologic's
growing portfolio of gynecologic solutions, developed with the
patient and physician in mind," said Sean
Daugherty, President of GYN Surgical Solutions at Hologic.
"This addition to the MyoSure product suite signals our ongoing
commitment to providing effective surgical solutions that can be
performed in office to address our customers' needs and improve the
overall patient experience."
Other devices in the MyoSure suite of products include the
MyoSure®, MyoSure® REACH, MyoSure®
XL, and MyoSure® LITE devices.
For more information about the MyoSure
MANUAL device, please see complete Instructions for Use .
About Hologic
Hologic, Inc. is an innovative medical technology company
primarily focused on improving women's health and well-being
through early detection and treatment. For more information
on Hologic, visit www.hologic.com.
Hologic, MyoSure, 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.
Important Safety Information
The MyoSure® MANUAL Tissue Removal Device is intended for
hysteroscopic intrauterine procedures by trained gynecologists to
resect and remove tissue. The MyoSure MANUAL Tissue Removal Device
should not be used in a patient who is pregnant or suspects
pregnancy, has clinical evidence of an active pelvic infection or
history of a recent pelvic infection, or has cervical malignancies
or previously diagnosed uterine cancer.
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
- Committee on Practice Bulletins—Gynecology. Practice bulletin
no. 128: diagnosis of abnormal uterine bleeding in
reproductive-aged women. Obstet Gynecol. 2012;120:197-206.
doi: 10.1097/AOG.0b013e318262e320
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SOURCE Hologic, Inc.