Superior Performance. Lower Dose.*1,2

World’s first and only 3D breast biopsy

Breast and Skeletal Health Solutions

AffirmTM Breast Biopsy Guidance SystemFor Stereotactic and Tomosynthesis Interventional Procedures

2 | | 3

PIONEER LEADER

What do you need most in breast biopsy?

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 Genius™ 3D Mammography™ exam—which

finds 41% more invasive cancers and offers a 21%

improvement in biopsy positive predictive value

compared with 2D mammography3—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-clicktargeting!

ACCURACY

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.

• 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.

Setting the Standard in Breast BiopsyThe 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

stereotactic biopsy, resulting in more accurate, faster procedures; 1-2

and, at a lower patient dose.

www.Hologic.com/Affirm or call your Hologic representative for more information.

13minute average

3D biopsy procedure1,2

Visit

Affirm 3D biopsy:

Designed to remove guesswork.

efficient. accelerated. precise.*1-2 MORE

4 | | 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.

6 | | 7

STREAMLINED

A Comprehensive SolutionThe 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.

Hologic breast health solutions

All-in-one Selenia Dimensions system offers:

• Direct capture digital mammography

• Low-dose Genius 3D Mammography exams

• 2D and 3D breast biopsy procedures

• Wire localization

• Contrast Enhanced 2D imaging (available with 3D Mammography imaging)

allow physicians to meet the needs of the broadest spectrum of patients.

Affirm breast biopsy guidance system SecurMark® biopsy site markers ATEC® and Eviva® breast biopsy systems Trident™ specimen radiography system

• The world’s first commercially available breast tomosynthesis system proven to be clinically superior to 2D mammography3-5

• Add-on and prone breast biopsy guidance systems

• The world’s first and only 3D breast biopsy with superior performance to 2D biopsy1-2

• Vacuum-assisted breast biopsy systems utilizing the widest variety of needle sizes

• Biopsy site markers

• Specimen radiography system utilizing a direct capture digital detector

A solution that grows with you.

3D

INNOVATIVE

The Affirm System— World’s first and only 3D breast biopsy system

with superior performance to 2D biopsy. 1-2

Selenia Dimensions system’s Genius 3D Mammography exam— World’s first breast tomosynthesis exam with proven superior clinical performance to 2D mammography.3-5

Setting the gold standard in imaging and biopsy

PB-00090 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, Genius, 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.

www.hologic.com | info@hologic.com | www.breasttomo.com | www.genius3dmammography.com | +1.781.999.7300

The Selenia Dimensions system with its Genius 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 swift accuracy in an all-in-one system. It’s revolutionizing the industry and how you look at biopsy.

The Affirm breast biopsy guidance system:

Faster. Easier. More Precise.*1-2

Revolutionizing Mammography

www.Hologic.com/Affirm or call your Hologic

representative for more information.

VISIT

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. 2015 274:3, 654-662 E-pub 2014 Nov 12. 2. 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. 2014 July;311(24):2499-2507. Epub 2014 June 24. 4. 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. 2013 Jan; 266(1):104-13. Epub 2012 Nov 20. 5. FDA PMA submission P080003 6. 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. 7. 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.

Genius 3D Mammography available on the Hologic Selenia Dimensions 3D system.*Compared to stereotactic (2D) biopsy.