MARLBOROUGH, Mass.,
Sept. 26, 2017 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) today announced the commercial
availability of its new SmartCurve™ breast stabilization system,
which has been clinically proven to deliver a more comfortable
mammogram without compromising image quality, workflow or
dose.1 The SmartCurve system is available
exclusively with Hologic's Genius™ 3D
Mammography™ exam, the only mammogram that detects
more invasive cancers, reduces false positives, and is FDA approved
as superior to conventional 2D mammography for all women, including
those with dense breasts.2,3,4
For years, women have reported avoiding regular mammograms due
in large part to the fear of discomfort associated with breast
compression. In fact, a recent survey of 10,000 women found that
fear of physical discomfort was the top reason cited for avoiding a
mammogram by women who never had one.5 With this in
mind, Hologic's research and development team, led by Tracy Accardi, Global Vice President of Research
and Development, set out to reduce breast pain without compromising
image quality or exam accuracy.
"As a woman, I know firsthand that all too often, annual
mammograms are considered a necessary evil. We understand the
critical role the exam plays in the early detection of breast
cancer, but we know how uncomfortable, and sometimes even painful,
the exam can be," said Accardi. "The associated anxiety causes many
women to avoid or delay this potentially life-saving exam,
something we set out to change when developing the
first-of-its-kind SmartCurve system."
Breast pain experienced during a mammogram is directly related
to the time spent under compression and the pressure distribution
on the breast, two factors that must be addressed to improve the
mammography experience. The SmartCurve system features a
proprietary curved surface that mirrors the shape of a woman's
breast to reduce pinching and allow better distribution of force
over the entire breast. The system also features proprietary image
processing algorithms that ensure the preservation of image quality
and accuracy. The SmartCurve system, combined with the fastest
3D™ mammogram available, makes the Genius exam the
obvious choice for women wanting a more accurate exam that is also
more comfortable.
In a recent clinical study comparing the SmartCurve breast
stabilization system to traditional flat paddle compression, the
SmartCurve system improved comfort in 93 percent of women who
reported moderate to severe discomfort with standard compression.
In addition, 95 percent of those surveyed would recommend
facilities that use the system.1 The system includes
options to accommodate a majority of women and breast sizes, and
can be used with Hologic's MammoPad® breast cushion for even
greater comfort.6
In addition to providing women with increased comfort and the
accuracy they have come to expect from the Genius exam, the
SmartCurve system's image processing algorithm ensures there is no
change in positioning or workflow for radiologists and
technologists administering the exam. Clinicians can feel confident
they are offering patients an improved experience while maintaining
efficiency within their facilities.
"Hologic is the world leader in breast cancer screening
technology, and with that leadership comes a responsibility to
develop products that provide optimal patient satisfaction without
sacrificing clinical performance," said Pete Valenti, Hologic's Division President,
Breast and Skeletal Health Solutions. "We are thrilled to introduce
the new SmartCurve system which, when used with the Genius exam, is
the first and only 3D mammography system that is clinically proven
to deliver a more comfortable and more accurate mammogram, compared
to 2D mammography alone. This game-changing product is yet another
example of our dedication to innovation designed to meet the needs
of our customers and their patients."
Hologic's Genius exam is the only mammogram clinically proven to
detect 20 to 65 percent more invasive breast cancers compared to 2D
mammography alone.2 It also reduces unnecessary
callbacks and is the only mammogram FDA approved as superior to
conventional 2D mammography for women with dense
breasts.3-4
Sheryl Crow, Genius exam
spokeswoman, said, "I've already been telling women that the Genius
exam is the best option for their annual screening. Now that it's
also a more comfortable exam thanks to the SmartCurve system, I'm
urging women everywhere to stop making excuses and ask their
doctors about the Genius exam today."
The SmartCurve system is available standard on Hologic's new
3Dimensions™ mammography system and as an enhancement option to
existing Hologic Selenia® Dimensions® systems.
The Genius™ 3D Mammography™ exam is
only available on a Hologic® 3D Mammography™ system. The exam
consists of a 2D and 3D™ image set, where the 2D image can be
either an acquired 2D image or a 2D image generated from the 3D™
image set. There are more than 4,000 Hologic 3D Mammography™
systems in use in the U.S., so women have convenient access to the
Genius exam. To learn more about the Genius exam, visit
http://www.Genius3DNearMe.com.
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, SmartCurve, Genius, 3D, 3D Mammography, MammoPad,
3Dimensions, Selenia and 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.
Forward-looking Statement Disclaimer:
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
*Compared to standard compression
1 Smith, A. Improving Patient Comfort in Mammography.
Hologic WP-00119 Rev 001 (2017).
2 Results from Friedewald, SM, et al. "Breast cancer
screening using tomosynthesis in combination with digital
mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13),
non-randomized, historical control study of 454,000 screening
mammograms investigating the initial impact the introduction of the
Hologic Selenia® Dimensions ® on screening outcomes. Individual
results may vary. The study found an average 41% (95% CI: 20-65%)
increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast
cancers per 1000 screening exams were found in women receiving
combined 2D FFDM and 3D™ mammograms acquired with the
Hologic 3D Mammography™ system versus women receiving
2D FFDM mammograms only.
3 Bernardi D, Macaskill P, Pellegrini M, et. al. Breast
cancer screening with tomosynthesis (3D mammography) with acquired
or synthetic 2D mammography compared with 2D mammography alone
(STORM-2): a population-based prospective study. Lancet Oncol. 2016
Aug;17(8):1105-13.
4 U.S. Food & Drug Administration Premarket Approval
(PMA). FDA.gov
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080003S005 accessed
June 5, 2017.
5 Kadence International, Ten Thousand Quantitative
Findings Research Study (5107), April
2017.
6 Coryell T. Increasing Mammography Tissue Acquisition
through Positioning Training and Use of a Foam Breast Cushion.
National Consortium of Breast Centers, 16th Annual National
Interdisciplinary Breast Conference, Las
Vegas, NV (2006)
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SOURCE Hologic, Inc.