Superior Performance. Lower Dose.* 1,2. World s first and only. 3D breast biopsy. Breast Biopsy Guidance System. Affirm

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1 World s first and only 3D breast biopsy Superior Performance. Lower Dose.* 1,2 TM Affirm Breast Biopsy Guidance System For Stereotactic and Tomosynthesis Interventional Procedures Breast and Skeletal Health Solutions

2 PIONEER What do you need most in breast biopsy? ACCURACY The Affirm is a proven 2D/3D breast biopsy guidance system that accurately targets subtle lesions fast through its pioneering technology. Working in tandem with the Selenia Dimensions system s Hologic 3D Mammography exam which finds 41% more invasive cancers and offers a 21% improvement in biopsy positive predictive value compared with 2D mammography 3 you can now scroll through 3D Mammography data, select a slice and target, with one click, areas that may be difficult or impossible to visualize in other modalities. One-click targeting! 2

3 LEADER Setting the Standard in Breast Biopsy The Affirm system s patent-pending technique takes breast intervention to a new level of performance. The unique 10-degree angled biopsy approach provides an unobstructed view of lesions, allowing radiologists to see them clearly and quickly. Plus, the one-click targeting from a tomosynthesis slice brings superior performance compared to 13 minute average 3D biopsy procedure 1,2 stereotactic biopsy, resulting in more accurate, faster procedures; 1-2 and, at a lower patient dose. Hard-to-detect and difficult-to-access cases are made easy with the Affirm system s innovative technique, which is designed to remove challenges from difficult cases. Affirm 3D biopsy: MORE efficient. accelerated. precise.* 1-2 Designed to remove guesswork. Allows seamless user interface with the all-in-one, advanced Selenia Dimensions acquisition workstation. Provides easy transition from screening to diagnostic to interventional procedures for optimal system versatility. Implements full utilization of Selenia Dimensions 70 cm Source to Image Distance (SID), the longest in the industry positions patients and biopsy devises with complete ease. Offers full views with its unique 10 angled biopsy approach, while maintaining automated Cartesian targeting. Targets subtle legions fast with its pinpoint, one-click targeting with Affirm 3D biopsy, designed for accuracy. Visit or call your Hologic representative for more information. 3

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5 A SOLUTION Smart Technology Automatically moves to the correct tube head position when the exposure switch is pressed. Accurately targets difficult lesions including those only found only with 3D Mammography imaging. Efficient and accurate targeting provide visual feedback for up to six targets per procedure. Allows enhanced flexibility in positioning and accommodates all breast sizes with its large SID, breast biopsy imaging field of view (up to 18 cm x 24 cm) and 360 degree access. Fully integrated user interface on the Selenia Dimensions console provides easy-to-use, intuitive controls and simplified workflow. Flexible Platforms Are Necessary The Affirm system s versatile design enables efficient use with a wide range of biopsy devices. Pre-programmed settings for Hologic Eviva and ATEC biopsy systems offer quick and efficient set-up, eliminating math and reducing procedure times. The Affirm system s paddle kit includestwo standard biopsy paddles and one paddle designed for managing difficult axillary positioning. Clear paddles are proven to expedite lesion re-identification. The paddles smooth curvature offer greater patient comfort and enhanced breast tissue grip. The 3D biopsy option enables streamlined targeting of areas found under 3D imaging, using less procedure steps and lowering patient dose.* 1-2 Ergonomics Are Important The Affirm system s compact design allows for complete installation in seconds. It is easily transportable and weighs only 7 kg (15 lb). An integrated design leverages Selenia Dimensions 70 cm SID to provide larger clearance for installation of biopsy devices and for patient positioning. The biopsy control module can be positioned on either side of the system, ensuring optimal access. The Affirm system is convenient for centers using multiple Selenia Dimensions systems who want versatile mammography and biopsy rooms. 5

6 STREAMLINED A Comprehensive Solution The Affirm system is a leading-edge technology that is streamlined within the same imaging suite. This advanced, 2D or 3D biopsy solution is a quick and easy transition, from mammography to interventional procedures, making it cost-effective and space-saving. The Affirm system is designed to help maintain your continuum of care. Plus, the ergonomic design can also expand its range of offerings with multiple Selenia Dimensions system use. A solution that grows with you. All-in-one Selenia Dimensions system offers: Direct capture digital mammography Low-dose Hologic 3D Mammography exams 2D and 3D breast biopsy procedures Wire localization Contrast Enhanced 2D imaging (available with 3D Mammography imaging) Affirm breast biopsy guidance system SecurMark biopsy site markers 6

7 Hologic breast health solutions allow physicians to meet the needs of the broadest spectrum of patients. The world s first commercially available breast tomosynthesis system proven to be clinically superior to 2D mammography 3-5 Add-on and prone breast biopsy guidance systems The world s first and only 3D breast biopsy with superior performance to 2D biopsy 1-2 Vacuum-assisted breast biopsy systems utilizing the widest variety of needle sizes Biopsy site markers Specimen radiography system utilizing a direct capture digital detector ATEC and Eviva breast biopsy systems Trident specimen radiography system 7

8 INNOVATIVE The Affirm breast biopsy guidance system: Faster. Easier. More Precise.* 1-2 Revolutionizing 3DThe Selenia Dimensions system with its Hologic 3D Mammography exam is a leader for today and tomorrow. The easy-to-use Affirm is a next-generation biopsy guidance system designed to enable Mammography swift accuracy in an all-in-one system. It s revolutionizing the industry and how you look at biopsy. Setting the gold standard in imaging and biopsy The Affirm System World s first and only 3D breast biopsy system with superior performance to 2D biopsy. 1-2 Selenia Dimensions system s Hologic 3D Mammography exam World s first breast tomosynthesis exam with proven superior clinical performance to 2D mammography. 3-5 VISIT or call your Hologic representative for more information. Hologic 3D Mammography available on the Hologic Selenia Dimensions 3D system. *Compared to stereotactic (2D) biopsy. 1. 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 :3, E-pub 2014 Nov 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). 3. Friedewald S, Rafferty E, Rose S, et al. Breast Cancer Screening using Tomosynthesis in Combination with Digital Mammography. Journal of the American Medical Association July;311(24): Epub 2014 June Rafferty E, Park J, Philpotts L, et al. Assessing Radiologist Performance Using Combined Digital Mammography and Breast Tomosynthesis Compared with Digital Mammography Alone: Results of a Multicenter, Multireader Trial. Radiology Jan; 266(1): Epub 2012 Nov FDA PMA submission P 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 Jun;271:3, Epub 2014 Jan 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 Jun;271(3): Epub 2014 Jan info@hologic.com PB Rev 005 (05/15) US/International 2015 Hologic Inc. All rights reserved. Specifications subject to change without notice. Hologic, 3D Mammography, Affirm, ATEC, Dimensions, Eviva, SecurMark, Selenia, Trident and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, ebroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologic representative or write to womenshealth@hologic.com.