--Designed to Simplify Intrauterine Tissue Removal In Theater
and In-Office--
MARLBOROUGH, Massachusetts,
Jan. 3, 2018 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today that the
MyoSure® MANUAL device, which was designed to simplify
tissue removal procedures regardless of setting, has received CE
mark in Europe. The MyoSure MANUAL
device joins the MyoSure suite of gynecologic surgical products
that offer simple and effective solutions to resect and remove
tissue.
Hologic offers the complete MyoSure system, which is a minimally
invasive hysteroscopic treatment for women with problematic tissue
that requires no cauterization, ultimately preserving 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
"There is an increased demand to simplify tissue removal
procedures regardless of where they are being performed, in-office
or in the theater. We continuously look to meet this need by
developing innovative solutions that provide flexibility and
convenience for both physicians and patients in any setting,"
said Edward Evantash, M.D., Medical Director and Vice
President of Medical Affairs, Hologic. "The MyoSure MANUAL device
is designed to simplify tissue removal procedures in theatre,
ambulatory or outpatient settings, requiring minimal set up and no
fluid management capital equipment, while offering direct
visualization when used with the MyoSure hysteroscope."
The MyoSure MANUAL device has a fully integrated vacuum with no
external suction required. It involves the support of a
one-liter saline bag – there is no need for a controller or
additional fluid management capital equipment. 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. Other devices
in the MyoSure suite of products include the MyoSure®,
MyoSure® REACH, MyoSure® XL, and
MyoSure® LITE devices.
"The MyoSure MANUAL device is an exciting addition to our
growing portfolio of gynecologic solutions in Europe, all of which have been developed with
the patient and physician in mind," said Jan Verstreken, Hologic's
President, EMEA & Canada.
"This new device expands our MyoSure suite of products, which
provide solutions for a wide range of pathologies. It indicates our
ongoing commitment to meeting our customers' needs and improving
their patients' experience by offering solutions that are effective
and convenient."
For more information about the MyoSure MANUAL device, please
visit www.myosure.com/manual. For women looking for more
information on abnormal uterine bleeding, visit
www.wearwhiteagain.co.uk.
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.
Media Contact:
Jane
Mazur
+1 508.263.8764 (direct)
+1 585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact:
Michael
Watts
+1 858.410.8588
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
Photo -
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