Fastest, Highest Resolution Breast Tomosynthesis System is
Designed to Increase Clinical Confidence, Accuracy and
Patient Comfort
MARLBOROUGH, Massachusetts,
Sept. 11, 2017 /PRNewswire/ --
Hologic, Inc. (Nasdaq: HOLX) announced today that the 3Dimensions™
mammography system, the fastest, highest resolution breast
tomosynthesis system ever, is available for purchase in
Europe.1 The new
product is the latest addition to Hologic's portfolio of
market-leading breast cancer screening, diagnostic and
interventional solutions. It offers a variety of groundbreaking
features designed to provide higher quality 3D™ images for
radiologists, enhanced workflow for technologists, and a more
comfortable mammography experience, with low-dose options, for
patients.
Hologic is the world leader in breast cancer screening
technology and pioneered the 3D Mammography™ exam, which detects up
to 65 percent more invasive breast cancers and is the only
mammogram approved by the U.S. Food and Drug Administration as
superior for women with dense breasts compared to 2D
alone.2,3
"We are excited to introduce our new 3Dimensions mammography
system, a major advance in Hologic's mission to expand our
leadership in breast health through transformational technology
that is rooted in meaningful customer insights and supported by
superior clinical evidence," said Pete
Valenti, Hologic's Division President, Breast and Skeletal
Health Solutions. "The 3Dimensions system offers a number of
innovative features that improve image clarity and help manage
dose, setting it apart from every other screening technology on the
European market."
The new 3Dimensions system features Clarity HD high-resolution
3D™ imaging, which provides the industry's fastest, highest
resolution 3D™ images to accelerate screening and analysis. The
system is designed to clearly reveal subtle lesions and fine
calcifications to help pinpoint cancers early. Clarity HD
technology's advanced detector and innovative 3D™ imaging algorithm
work together to deliver exceptional 3D™ images, regardless of
breast size or density. Designed to increase clinical confidence
and achieve more accuracy the first time, Clarity HD reduces
recalls by up to 40 percent compared to 2D
alone.4,5,6,7
"Clinicians across Europe have
made clear their desire for breast cancer screening technology that
offers improved accuracy, clarity and workflow, and the 3Dimensions
system addresses each of those specific areas," said Jan
Verstreken, Hologic's Regional President for EMEA and Canada. "We are thrilled to introduce this
comprehensive solution, which will undoubtedly make a positive
impact on European radiologists, technologists and patients
alike."
In addition, the 3Dimensions system offers Intelligent 2D™
imaging technology, which works with Clarity HD technology to
deliver unprecedented clarity, contrast and detail at a lower
dose.1,8 Intelligent 2D imaging technology features
smart mapping, which enables radiologists to instantly move from
suspicious areas detected on the 2D image to the point of interest
on the 3D slice, saving time and optimizing
workflow.9
The 3Dimensions system also includes the new SmartCurve™ breast
stabilization system, which is clinically proven to deliver a more
comfortable mammogram without compromising image quality, workflow
or dose.10 The SmartCurve system has been shown to
improve comfort in 93 percent of women surveyed who reported
moderate to severe discomfort with standard
compression.10 The system features a curved compression
surface that mirrors the shape of a woman's breast to reduce
pinching and allow uniform compression over the entire breast.
Advanced processing software, specifically developed for the
SmartCurve system, ensures optimal image quality.
Another feature available with the 3Dimensions system is the
Quantra™ 2.2 breast density assessment software, which enables
standardization in patient protocols, providing reproducible and
consistent breast density assessment.
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, 3D, 3Dimensions, Clarity HD High-resolution,
Intelligent 2D, SmartCurve, Quantra, 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
References
1 Data on file.
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% increase and that
1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1,000
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 FDA submissions P080003, P080003/S001, P080003/S004,
P080003/S005.
4 Zuckerman SP, Conant EF, Keller BM, et al.
Implementation of Synthesized Two-dimensional Mammography in a
Population-based Digital Breast Tomosynthesis Screening Program.
Radiology. 2016 Dec;281(3):730- 736.
5 Skaane P, Bandos A, Eben EB, et al. Two-view digital
breast tomosynthesis screening with synthetically reconstructed
projection images: comparison with digital breast tomosynthesis
with full-field digital mammographic images. Radiology. 2014
Jun;271(3):655-63.
6 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.
7 McDonald ES, Oustimov A, Weinstein SP, et al.
Effectiveness of Digital Breast Tomosynthesis Compared With Digital
Mammography: Outcomes Analysis From 3 Years of Breast Cancer
Screening. JAMA Oncol. 2016 Jun
1;2(6):737-43.
8 Compared to 2D alone
9 Feature is used in combination with SecurView®DX
diagnostic review workstation mapping tool in v9.0.1 and above.
10 Smith, A. Improving Patient Comfort in Mammography.
Hologic WP-00019 Rev 001 (2017).
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