Affirm® Upright Breast Biopsy Guidance System
The world's first1 3D breast biopsy guidance system gives you the power to quickly transition from screening to 2D/3D interventional procedures, using any Hologic 3D mammography-capable system.
Simple Switch from Screening to Intervention
This simple add-on to any Hologic Mammography™ capable system, enables you to quickly perform 2D or 3D™ breast biopsies in 13 minutes2* with the same imaging equipment as for mammography exams. Plus, with the lateral arm upright biopsy accessory gives you even more flexibility to access challenging lesion locations.
Simplify the Breast Biopsy Process
Perform fast, effective biopsies with the Affirm Upright System. This easy add-on biopsy guidance solution for Selenia® Dimensions® and 3Dimensions® Systems, helps to streamline workflow and accelerate procedures.
Superior Image Quality Compared to 2D
Pinpoint subtle lesions and faint clarifications, including those that may only be visible using tomosynthesis, with the 3D biopsy option.
Streamlined Workflow
Efficient, fast, easy to learn and use. The system provides a simplified user interface to help deliver a fast tomosynthesis guided biopsy procedure with fewer steps and a lower patient dose.2
Versatile Solutions
Transition from screening to interventional procedures and biopsies on a wide spectrum of patients, either seated or decubitus. Quickly and easily switch between standard and lateral needle approaches.
Unlock the Advantage of Time
The Breast Health Continuum of Care offers integrated solutions for clinical confidence, workflow efficiency and compassionate patient care. It gives more women, more time in better health.
The Affirm Upright Breast Biopsy Guidance System is part of the Hologic Biopsy Solution.
Affirm® Lateral Arm Upright Biopsy Accessory
This versatile, easy-to-use device enables needle access parallel to the detector, from either the lateral left or lateral right position.
- Easy lesion access: improve access for thinly compressed breasts by approaching the lesion perpendicular to the direction of compression.
- Flexible patient positioning: the Affirm lateral arm offers various options in biopsy rooms where decubitus positioning or rotating the C-arm may not be possible. Patients can often remain seated without sacrificing lesion accessibility.
- Intuitive needle visualisation: experience improved visualisation of the biopsy needle in the breast without imaging artifacts found in the standard approach. It’s easier to see the needle aperture and more intuitive to make adjustments.
Visit Our Virtual Hospital
Browse our portfolio of Breast Health solutions in 3D. See how you can unlock the advantage of time across the entire Breast Continuum of Care.
A Scalable Breast Biopsy Solution
Our products are designed to work together. Discuss your clinical needs with our experienced team to customise the best solution that suits your requirements. Browse the relevant options below.
3Dimensions™ Digital Mammography System
Reveal fine details with the fastest, highest resolution 3D Mammography exam,3 using our advanced detector and innovative 3D imaging technologies. They are designed to help detect more invasive cancers with confidence. With the integration of additional AI-powered solutions, the 3Dimensions is the smart, comprehensive platform for breast cancer detection, workflow optimisation and risk assessment.
Faxitron® Core Specimen Radiography System
The compact unit can be located directly in the stereotactic suite, only steps from the table. With one touch of a button, a successful biopsy procedure is confirmed. Images can be instantly sent to multiple destinations without interrupting the mammography workflow.
Eviva® Breast Biopsy System
The Eviva Breast Biopsy System was designed with the flagship technology of the Hologic ATEC® Breast Biopsy Device. It has additional features for optimal use during stereotactic or 3D biopsy procedures. Breast biopsies using Eviva provide clinicians with the highest quality core samples.4
Breast Biopsy Site Markers
The Hologic range of biopsy site markers come in multiple shapes, gauges and lengths. The markers are compatible for use with X-ray, ultrasound and MRI guided biopsies, and provide options for great long-term visibility. They allow you to identify sites with confidence. An easy to use deployment device is included.
Akrus™ Mammography and Biopsy Positioning Chair
The Akrus chair is easy to use, versatile and ergonomically designed for screening, diagnostic and biopsy imaging. It allows a variety of positioning options, providing upright and decubitus in all mammography projections including magnification views. The Akrus chair is a valuable addition to any facility.
Video Resources
13 Minutes Average Procedure Time2
Helps reduce time under compressions, lowers X-ray dose, and offers a better patient experience.2,5
Evidence. Insight. Collaboration.
Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.
*Average procedure time
- https://www.prnewswire.com/news-releases/commercial-release-of-3d-breast-tomosynthesis-biopsy-option-strengthens-hologics-position-as-provider-of-the-nations-most-comprehensive-portfolio-of-interventional-breast-health-solutions-215568061.html last accessed 1st March 2023.
- 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.
- Compared to other standard models. Rocha Garcia, A.M., Mera Fernandez, D. Breast tomosynthesis: State of the art. Radiologia. 2019;61(4):274-285.
- Hologic Data On File: MISC-06068 Rev001. Eviva Audit, 155 respondents comprised of radiologists, RAD Admins, Directors of Radiology, and Breast Surgeons. Identifying Optimal Claims for the Eviva Breast Biopsy Device, July 2015. Kadence International report released April, 2020.
- 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).
Safety Data Sheets
Package Inserts
2797
0482
Hologic BV, Da Vincilaan 5, 1930 Zaventem, Belgium.
Notified Body number wherever applicable
EC Representative Information wherever applicable