Invenia ABUS Key Considerations

Thank you for considering GE Healthcare for your ABUS screening program. GE Healthcare is a leader
in medical imaging in the US and worldwide. One of our key corporate initiatives is to help transform the
diagnosis and treatment of breast cancer from reactive to proactive.

It is from this perspective, that we propose our technology for your consideration, and to help you assess the
impact of launching an ABUS program for your patient population and institution.

1. Clinical Impact: The Invenia™ ABUS system has 93% were

INVASIVE
2. Enhanced Comfort and Image Quality: The Invenia ABUS
demonstrated a 55% relative increase in invasive Breast
*
cancer system uses Reverse Curve™ transducer technology,
detection over mammography alone for womenCancers with which is designed to conform to a woman’s anatomy.
dense breast tissue.1 Finding more cancers, at an earlier The Compression Assist feature provides 3 levels of
stage, has the potential to lead to lower mortality
DCIS
rates, compression. These features offer patient comfort, help
increased revenue, and better patient care. Invasive maintain edge to edge contact with the breast and deliver
The Invenia ABUS has both a screening and a diagnostic outstanding image quality and reproducibility.
indication for use, as well as being the only FDA-approved
system for screening women with dense breast93%
93% were tissue
were
INVASIVE Reverse Curve
based on a multi-center, prospective
Breast clinical study with
NODE
NEGATIVE Transducer
over 15,000 subjects. Cancers

In the study, the majority of mammographically occult

cancers detected were DCIS
invasive, small, and node negative.
Node Positive
Invasive Node Negative

93% were
93% were
INVASIVE 87% were
NODE
Breast SMALL
NEGATIVE
Cancers

3. Multi-planar Review of Two Views: The Invenia ABUS

DCIS Node Positive >19 mm review software allows the radiologist to review two
Invasive Node Negative <19 mm
(median 10 mm, mean 15.2 mm) breast volumes simultaneously, in both the coronal
and transverse planes. Assessing structures in multiple
perspectives may improve reading productivity and
93% were clinical confidence.
NODE 87% were
NEGATIVE SMALL

Node Positive >19 mm

Node Negative <19 mm
(median 10 mm, mean 15.2 mm)

87% were
SMALL

>19 mm
<19 mm
(median 10 mm, mean 15.2 mm)
4. User Repeatability and Patient Access: GE Healthcare offers 6. Mastery Program for Physicians: This program provides
accredited training for 3 operators per site. This prepares orientation and instruction on reading Invenia ABUS images
them to perform ABUS exams proficiently. Typically, either as an adjunct to screening mammography. Radiologists
ultrasound or mammography technologists perform the learn skills to help promote accurate and rapid
ABUS exam to provide seamless patient management interpretation of ABUS for screening using a consistent
from the mammogram to screening ultrasound. review methodology on the Invenia ABUS review software.
The extensive, progressive, step-wise training consists
5. Imaging Algorithms: Invenia ABUS is the 2nd generation of of 4 modules:
GE Healthcare’s ABUS technology. Tissue Enhancement, • Module I: 1 hour
Nipple Shadow Compensation, Chest Wall Detection and – Peer-to-peer webinar
Breast Border Detection algorithms are all designed • Module II: 2 hours
to eliminate distractions, and focus the radiologist’s – Self-paced tutorials
attention on the most important data – the anatomy. • Module III & IV: 4 hours
– Remote peer-to-peer ABUS interpretation quality
assessment
• Self-assessment: 1 hour
– Individualized performance feedback

7. Stand-Out in Your Market: With the FDA-approved claim

for breast cancer screening, you can market your breast
screening proven to help clinicians find more cancers in
Chest Wall Detection Tissue Enhancement Algorithm the dense breast population. A marketing kit is provided
with templates, examples and production files to help you
develop materials to inform referring physicians, educate
patients and reach out to your community.

All breasts are not the same.

Some are fatty, some are dense
and some are a mix.
Breast Density — What does it mean?
Breasts are made of fat and breast tissue. Some
women have more fat than breast tissue while others
have more breast tissue than fat. When there is more
breast tissue the breast is considered dense. On a
mammogram dense tissue looks white. Since masses
or lumps also appear white on a mammogram,
a suspicious lump may be masked by the dense
breast tissue.
Dense breast tissue is also linked with an increase
in the risk of developing breast cancer. Women with
extremely dense breast tissue have a 4 to 6 times
greater risk of developing breast cancer than women
who do not have dense breast tissue. Invenia ABUS
helps physicians look differently at dense breast tissue.
Look differently.
Invenia™ ABUS — the only breast cancer screening technology
FDA-approved* for detection in women with dense breast tissue.
Should I have an Invenia
ABUS screening exam?
Invenia ABUS breast cancer screening
is specifically developed to help doctors
find cancers hidden in dense breast
tissue, which may be missed by
mammography.
If you have dense breast tissue, like
40% of women in the U.S., the addition
of ABUS (Automated Breast Ultrasound)
screening can increase the detection
1
of cancers. Invenia ABUS screening along
with your screening mammogram will
help provide a clear evaluation of your
dense breast tissue.
The Invenia ABUS
screening experience.
From the moment you lie down on the
exam table, you’ll realize that Invenia
ABUS screening is completely unlike a
mammogram. A layer of lotion is applied
to your breast, and then a scanner is
firmly positioned on your breast to acquire
the images. The exam takes approximately
15 minutes and provides your doctor with
clear 3D ultrasound images. The physician
will review the ABUS screening images
along with your mammogram.
How the Invenia ABUS exam
is different
Unlike 2D or 3D mammography, which
uses radiation, Invenia ABUS screening
uses sound waves to create 3D pictures
of the breast tissue. Invenia ABUS is
the only FDA-approved system for
breast cancer screening when used
in combination with mammography
in women who have dense breast
tissue and no prior interventions.
Ask your doctor if an Invenia ABUS
screening would benefit you.
*FDA PMA P110006

Breast Border Detection Nipple Shadow Compensation

Scattered
Almost entirely Heterogeneously Extremely
fibroglandular
fatty dense dense
densities

Breast density is determined by the radiologist

who reads your mammogram and classifies the GE Healthcare
density into one of four categories. Your doctor will
tell you if you have dense breasts based on your
mammogram’s classification on the density scale.
Invenia™ ABUS Marketing Kit
1 Boyd et al, New England Journal of Medicine 2007;356:227-36 “Women with
© 2014 General Electric Company
dense tissue in 75% or more of the breast have a risk of breast cancer four
All rights reserved
to six times as great as the risk among women with little or no dense tissue.” imagination at work
January 2014
DOC1427614

8. ABUS Club: ABUS users are invited to join our online

community that offers resources to help implement,
refine and grow your ABUS service line.
www.abusclub.net

* Increase in sensitivity was associated with a decrease in overall specificity.

Brief Statement
The Invenia ABUS is indicated as an adjunct to mammography or breast cancer screening
in asymptomatic women for whom screening mammography findings are normal or
benign (BI-RADS® Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS
Composition/Density C or D), and have not had previous clinical breast intervention. The
device is intended to increase breast cancer detection in the described patient population.
The Invenia ABUS may also be used for diagnostic ultrasound imaging of the breast in
symptomatic women. See the device manual for detailed information, contraindications,
warnings, precautions, potential adverse events.
Imagination at work
www.gehealthcare.com. Product may not be available in all countries and regions.
Contact a GE Healthcare Representative for more information.
Data subject to change.
© 2016 General Electric Company.
GE, the GE Monogram, imagination at work, Invenia and Reverse Curve are trademarks
of General Electric Company.
Reproduction in any form is forbidden without prior written permission from GE.
Nothing in this material should be used to diagnose or treat any disease or condition.
Readers must consult a healthcare professional.

February 2016
ULT-0572-03.14-EN-US
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