The CE-Marked Affirm™ Prone Biopsy System
Provides Enhanced 2D/3D™ Biopsy Imaging and Faster,
Easier Access to the Breast [i]
MARLBOROUGH, Massachusetts,
March 2, 2016 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) announced today the European
launch of the CE-marked Affirm™ prone biopsy system —
the first dedicated prone biopsy system capable of both 2D and
3D™ imaging guided breast biopsies.
The new product is an important step forward in biopsy
technology — allowing radiologists to better target lesions found
during 3D MAMMOGRAPHY™ screening, as well as other
screening modalities — with exceptional imaging, improved workflow
and seamless, 360-degree access to the breast.
"As screening and diagnostic technology has advanced with
the widespread use of 3D MAMMOGRAPHY™, it has become
abundantly clear that prone biopsy technology was lagging behind,"
said Pete Valenti, Hologic's
Division President, Breast and Skeletal Health Solutions. "We
are excited to bring the Affirm™ prone biopsy system
to the European market, and in doing so, mark one of the biggest
steps forward in prone biopsy technology since the systems were
first introduced over 20 years ago. A significantly improved
imaging capabilityii and a streamlined workflow will
provide healthcare providers with increased confidence for these
critical procedures so that they can provide the best patient
experience."
The Affirm™ prone biopsy system expands Hologic's
breast biopsy portfolio, complementing the Company's
Selenia® Dimensions® mammography system and
Affirm™ upright biopsy system. This portfolio provides
radiology facilities all the options necessary to provide minimally
invasive breast biopsies for their patients without compromise.
Thousands of clinicians worldwide have trusted prone patient
positioning for breast biopsy as it supports the patient stably
throughout the procedure while isolating them from the biopsy
needle. This provides a better overall patient experience.
The new system will be unveiled at the annual European Congress
of Radiology meeting in Vienna,
Austria from March 2-6. ECR is
the largest medical imaging meeting in Europe and attracts participants from across
the world.
Hologic is offering several tomosynthesis-related events at
ECR:
- ECR Satellite Symposium, "The Use of 3D
MAMMOGRAPHY™
Exams in High Volume Screening," on Friday,
March 4 from 2:00 p.m. –
3:00 p.m.
- Seven Educational Sessions from March 3-5 focusing
on the clinical value of vacuum assisted 3D™ breast biopsy.
- Seven Educational Sessions from March 3-5 on the clinical use of 3D
MAMMOGRAPHY™ exams with a focus on reading and
interpreting cases.
In addition to the Affirm™ prone biopsy system,
other innovative products to be featured at ECR, include:
- Horizon™ bone densitometry (DXA) system, a single platform for
osteoporosis and obesity assessment;
- I-View™ software, the first and only Contrast Enhanced 2D
Mammography exam that can be combined with tomosynthesis;
- Low dose 3D MAMMOGRAPHY™ exams with C-View™
software, delivering superior clinical performance to 2D
mammography for all breast typesiii,iv,v in a faster,
more comfortable and lower dose 3D MAMMOGRAPHY™
exam;
- Affirm™ upright biopsy system for
Selenia® Dimensions®, the proven
3D™ breast biopsy system providing superior upright
biopsy performancevi,vii and
- Eviva® and ATEC® breast biopsy
systems, designed to conduct minimally invasive biopsy procedures
under stereotactic, tomosynthesis, ultrasound or MRI guidance.
For additional information on the Affirm™ prone
biopsy system, please visit www.affirmpronebiopsy.com, and for
registration details, email iims@hologic.com.
The Affirm™ prone biopsy system is not currently for sale in
the United States.
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, 3D, 3D Mammography, Affirm, ATEC, C-View, Dimensions,
Eviva, Horizon, Selenia, 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:
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
508.263.8764 (direct)
585.355.5978 (mobile)
jane.mazur@hologic.com
Investor Contact:
Michael Watts
858-410-8588
michael.watts@hologic.com
i Compared to the MultiCare® Platinum system.
ii Compared to existing dedicated prone biopsy
systems
iii FDA PMA submission P080003/S001 physician
labeling
iv Skaane P, Bandos A, Eben E, 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, 655-663. Epub 2014 Jan
24.
v Zuley M, Guo B, Catullo V, et al. "Comparison of
Two-dimensional Synthesized Mammograms versus Original Digital
Mammograms Alone and in Combination with Tomosynthesis Images."
Radiology. 2014 Jun;271(3):664-71. Epub 2014 Jan
21.
vi Schrading S, Martine D, Dirrichs T, et al.
"Digital Breast Tomosynthesis-guided Vacuum-assisted Breast Biopsy:
Initial Experiences and Comparison with Prone Stereotactic
Vacuum-assisted Biopsy." Radiology. 2014 Nov 11.
[vii] Smith A, Sumpkin J, Zuley M, et al. "Comparison of Prone
Stereotactic vs. Upright Tomosynthesis Guided Vacuum Assisted Core
Breast Biopsies." (paper presented at the annual meeting for the
Radiological Society of North
America. Chicago, Il,
November 2014).