MARLBOROUGH, Mass.,
April 21, 2016 /PRNewswire/
-- Hologic, Inc. (Nasdaq: HOLX) today announced the U.S. Food
and Drug Administration (FDA) clearance and commercial launch of
the Affirm™ prone biopsy system, the first dedicated prone biopsy
system to offer both 2D and 3D™ imaging-guided breast biopsies.
"At Hologic, we challenge ourselves to advance medical
technology so that healthcare professionals and patients can
benefit from innovative solutions that significantly improve
outcomes and patient experience, while also creating a powerful
economic model for our customers," said Pete Valenti, Hologic's Division President,
Breast and Skeletal Health Solutions. "The launch of our Affirm™
prone biopsy system is the most significant advancement in prone
biopsy technology since we introduced the first system more than 20
years ago. We identified a need for a minimally invasive,
stereotactic breast biopsy technology that marries the advances in
3D MAMMOGRAPHY™ exams with the prone positioning many doctors
prefer, and are excited to bring this new generation prone biopsy
system to market."
With a larger field of view than existing dedicated prone biopsy
systems, the new Affirm™ prone biopsy system allows radiologists to
better target lesions found during 3D MAMMOGRAPHY™ exams, as well
as other screening modalities. Furthermore, this new product
features a streamlined workflow with increased automation designed
to make using the system fast and easy.
With the patient lying prone, the biopsy system provides true
360-degree access to lesions using a fully integrated C-Arm.
Approach angles can be varied with minimal movement on the
patient's part, as the patient is supported stably throughout the
procedure. In addition to these important benefits for clinicians,
the system's design aims to increase patient satisfaction through
faster procedure times than Hologic's market leading MultiCare®
Platinum system, and comfortable prone positioning that eliminates
a direct view of the biopsy needle.
"Until now, we've been struggling to handle complex biopsies for
subtle lesions or faint calcifications that we are only able to
identify using 3D MAMMOGRAPHY™ exams," said Dr. Alejandro Tejerina of the Centro Patologia de la
Mama, Fundación Tejerina in Madrid,
Spain. "As an early testing site for the Affirm™ prone
biopsy system, we've had the opportunity to perform many biopsies
using this technology, and are pleased to report that this new
biopsy table has helped to solve our challenges. We are able to
visualize more tissue and have access to challenging lesion
locations, and the procedures are very fast."
The system is CE marked, and Hologic has begun installing
Affirm™ prone systems at leading imaging sites in Europe.
The Affirm™ prone biopsy system expands Hologic's breast biopsy
portfolio, complementing the Company's Genius™ 3D MAMMOGRAPHY™ exam
and Affirm™ upright biopsy system. This portfolio equips hospitals
and imaging centers with the options necessary to provide minimally
invasive breast biopsies for their patients.
The system is now available for order in the U.S. For additional
information on the Affirm™ prone biopsy system, please visit
www.affirmpronebiopsy.com.
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, Genius, MultiCare and the
Science of Sure are trademarks and/or registered trademarks of
Hologic, Inc., and/or its subsidiaries in the United
States and/or other countries.
Forward-Looking Statements
This news release may contain forward-looking information that
involves risks and uncertainties, including statements about the
use of Hologic mammography and breast biopsy systems. There can be
no assurance the systems will achieve the benefits described here,
or that such benefits will be replicated in any particular manner
with respect to an individual patient. The actual effect of the use
of the systems can only be determined on a case-by-case basis
depending on the particular circumstances and patient in question.
In addition, there can be no assurance that the systems will
achieve any expected level of sales or market share. Hologic
expressly disclaims any obligation to release publicly any updates
to the data or statements presented here to reflect any change in
the Company's 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
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SOURCE Hologic, Inc.