FDA Clearances the First 2D/3D Imaging-Guided Dedicated Prone Biopsy System of Hologic

 Hologic, Inc announced the U.S.  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.
Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said that 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.
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.
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