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Brevera® Breast Biopsy System

Real-time imaging for instant sample verification during breast biopsy procedures.1-3

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Breast Biopsy System

Update on Biopsy Needle Availability

Hologic is committed to the highest quality and is working urgently to address market shortages following a field safety notice and the removal of all Brevera® Breast Biopsy System 9 Gauge needles in December 2025. We are currently targeting return of the Brevera Breast Biopsy 9 Gauge needles to market by the end of the calendar year 2026.

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    In the interim, we are committed to supporting your operations through the following immediate actions:

    • Increasing Biopsy Needle Supply: We are significantly increasing the supply of Eviva® needles. This is backed by major investments in our internal manufacturing, including additional personnel resources and expanded manufacturing shifts.
    • Expediting Product Delivery: We are expediting shipping on all orders to ensure you receive essential supplies as quickly as possible.
    • Stabilising Inventory: Our teams are working closely with component suppliers to increase volumes and restore long-term inventory consistency.

    Eviva needles continue to be allocated through a multi pronged approach that considers historical ordering patterns prior to the field action, procedure volume and inventory levels to support planning.

    Throughout this process, we are working closely with local country competent authorities in communicating ongoing activities and return to market for the needles. We remain committed to providing regular updates here as they become available. Customers may contact their Hologic sales representative with any questions.

      Overview

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      Overview

      Gain the Advantage of Time

      We understand that reducing time under compression for your patients during a breast biopsy procedure is essential to deliver an improved patient experience. The Brevera Breast Biopsy system in combination with CorLumina® Imaging Technology streamlines the entire breast biopsy process from start to finish. This includes real-time imaging for instant verification and automated post-biopsy specimen handling.1-3

      Reduced Procedural Steps

      There is no need to move to another room for imaging, no waiting for sample verification and fewer interruptions to your screening schedule. Instead, you can experience the detailed, real-time, accurate information you need to improve patient care and enhance your clinical workflow.1-3

      Improve Patient Experience

      Fast, accurate and streamlined procedures mean less time under compression and result in a more positive and compassionate biopsy experience for you and your patient.2,3

      Enhance Workflow

      An intuitive user interface, real-time imaging, and automated specimen collection and separation work together to save facilities an average of 13 minutes per procedure.2,3

      Increase Accuracy

      Real-time imaging delivers a wealth of information at the point of care – so you can make informed clinical decisions with confidence.1-3

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      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 Brevera Breast Biopsy System is part of the Hologic Biopsy Solution.

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      Illustration of Hologic Breast Health Continuum of Care with Radiology

      Key Features & Benefits

      • Instant tissue verification with CorLumina imaging technology1
      • Intuitive software and a high-resolution, touchscreen monitor to quickly pinpoint subtle lesions and identify faint calcifications1,2
      • Wireless connectivity to easily share images and transfer patient records1
      • New disposable needle, which produces 54% less waste4
      • Automated tube-head, pre-programmed needle parameters and one-click targeting1,2
      • Remote operation and physician-controlled sampling to improve speed and efficiency1
      • Independently rotating arm to access challenging lesions with a lateral needle approach1,2
      • Integrated pain management and quiet operation to help improve the patient experience1
      • 8-second acquisition and imaging cycle means more actionable information at the point of care1

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      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. 

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      Image rendering of Breast Biopsy Suite

      A Comprehensive Range of Compatible Breast Biopsy Markers

      The Hologic range of biopsy site markers for use with the Brevera Breast Biopsy Device come in multiple shapes, gauges and lengths. All markers come with blunt tip deployment and an ergonomic and easy to use deployment device included.

      Intelligently designed to provide long-term ultrasound visibility, all Tumark markers are non-bioabsorbable, biocompatible permanent markers offering excellent visibility under mammography at deployment and are designed to minimise movement.6

      Biopsy Site Marker on white background

      Tumark® Vision

      The Tumark Vision Biopsy Site Marker is for use with the Brevera Breast Biopsy Device, and available in both petite and standard size. The unique 3D structure anchors firmly in the tissue, with a mesh structure made of 48 individual wires. Options available: 18G, 127.5mm or 123.5mm length.

      Markers from the Tumark family are used for marking biopsy sites and suspicious lesions in the breast tissue. 18-gauge thin, sharp puncture cannulas enable precise marking and ensure minimally invasive treatment.5 The ergonomic handle design and side deploy mechanism allow for single-handed use under ultrasound-guidance.6 Sharp bevelled tip assists with introduction into the breast under ultrasound guidance.7

      Due to their shapes, the markers anchor firmly in the tissue and are detectable in ultrasound, X-ray and MRI. All markers are made from the biocompatible implant material Nitinol and remain visible in the tissue.

      • Intelligent 3D design provides very good visibility in ultrasound, X-ray and MRI5
      • The mesh structure in a 3D spherical design leads to high echogenicity in ultrasound imaging regardless of transducer positions5
      • Markers expand into shapes upon deployment and anchor firmly in the tissue5
      • Ergonomic delivery device handles and side deploy mechanism allow for single-handed use6
      Biopsy Site Marker on white background

      Tumark® Professional Q

      The Tumark Professional Q Biopsy Site Marker is for use with the Brevera Breast Biopsy Device, and available in both petite and standard size. The Q-shape becomes firmly anchored in the tissue.5 The slightly open, spiral-shaped design, sandblasted and twisted material designed to provide visibility in ultrasound.6 Options available: 18G, 129.5mm or 125.5mm length.

      Markers from the Tumark family are used for marking biopsy sites and suspicious lesions in the breast tissue. 18-gauge thin, sharp puncture cannulas enable precise marking and ensure minimally invasive treatment.5 The ergonomic handle design and side deploy mechanism allow for single-handed use under ultrasound-guidance.6 Sharp bevelled tip assists with introduction into the breast under ultrasound guidance.7

      Due to their shapes, the markers anchor firmly in the tissue and are detectable in ultrasound, X-ray and MRI. All markers are made from the biocompatible implant material Nitinol and remain visible in the tissue.

      • Markers expand into shapes upon deployment and anchor firmly in the tissue5
      • Intelligent design provides tissue fixation5
      • Distinctly identifiable shapes for ease of identifying between biopsy sites6
      • Ergonomic delivery device handles and side deploy mechanism allow for single-handed use6
      Biopsy site marker in white background

      Tumark® Professional X

      The Tumark Biopsy Site Marker is for use with the Brevera Breast Biopsy Device, and available in both petit and standard size. Lateral anchor “feet” provide secure anchoring in the tissue5 and the marker is twisted shape with angled ends. Options available: 18G, 127.5mm or 123.5mm length.

      Markers from the Tumark family are used for marking biopsy sites and suspicious lesions in the breast tissue. 18-gauge thin, sharp puncture cannulas enable precise marking and ensure minimally invasive treatment.5 The ergonomic handle design allows for single-handed use under ultrasound-guidance.6 Sharp bevelled tip assists with introduction into the breast under ultrasound guidance.7

      Due to their shapes, the markers anchor firmly in the tissue and are detectable in ultrasound, X-ray and MRI. All markers are made from the biocompatible implant material Nitinol and remain visible in the tissue.

      • Lateral anchor feet provide secure anchoring in the tissue5
      • Markers expand into shapes upon deployment and anchor firmly in the tissue5
      • Distinctly identifiable shapes for ease of identifying between biopsy sites6
      • Ergonomic delivery device handles and side deploy mechanism allow for single-handed use6
      Mini cork biopsy site marker in white background

      SecurMark® Mini Cork

      The SecurMark Breast Biopsy Marker is for use with the Brevera Breast Biopsy Device, and available in two different gauge sizes. The marker consists of two pieces, a permanent marker and a bioabsorbable suture-like netting. Options available: 9G or 12G, 130mm length.

      SecurMark biopsy site markers are designed to minimise movement within the biopsy cavity.8 A study shows that SecurMark is the most highly visible upon ultrasound deployment and still highly visible at 6 weeks* post biopsy, which is crucial in case future breast intervention is necessary.9 The marker consists of two pieces: a permanent marker made of biocompatible titanium and a bioabsorbable suture-like netting that surrounds the metal.

      SecurMark Biopsy Site Markers utilise a rigid end-deploy delivery system that requires no pull-back for deployment. Markers are made of biocompatible titanium in 2 distinct shapes for Brevera Breast Biopsy Device, Mini Cork and Top Hat. Additional lengths options are available for use with Eviva® Breast Biopsy Device and ATEC® Breast Biopsy Device.

      Top hat biopsy site marker in white background

      SecurMark® Top Hat

      The SecurMark Breast Biopsy Marker is for use with the Brevera Breast Biopsy Device, and available in two different gauge and length sizes. The marker consists of two pieces, a permanent marker and a bioabsorbable suture-like netting. Options available: 9G or 12G, 130mm length.

      SecurMark biopsy site markers are designed to minimise movement within the biopsy cavity.8 A study shows that SecurMark is the most highly visible upon ultrasound deployment and still highly visible at 6 weeks* post biopsy, which is crucial in case future breast intervention is necessary.9 The marker consists of two pieces: a permanent marker made of biocompatible titanium and a bioabsorbable suture-like netting that surrounds the metal.

      SecurMark Biopsy Site Markers utilise a rigid end-deploy delivery system that requires no pull-back for deployment. Markers are made of biocompatible titanium in 2 distinct shapes for Brevera Breast Biopsy Device, Mini Cork and Top Hat. Additional lengths options are available for use with Eviva® Breast Biopsy Device and ATEC® Breast Biopsy Device.

      Cork biopsy site marker in white background

      TriMark® Cork

      The TriMark Biopsy Site Marker cork shape is for use with the Brevera Breast Biopsy Device, and available in two different gauge sizes. Options available: 9G or 12G, 130mm length.

      TriMark biopsy site markers are small, permanent radiopaque markers placed within the biopsy site during stereotactic 2D or 3D™ breast biopsy procedure for future identification of the biopsied area. TriMark Biopsy Site Markers are made of biocompatible titanium in 2 distinct shapes; cork and hourglass.

      Reliable and simple, their small size and smooth edges make them optimal for superficial lesions or for lesions close to the chest wall. All TriMark biopsy site markers include the deployment device and biopsy site marker for marking an open or percutaneous biopsy site.

      Hourglass biopsy site marker in white background

      TriMark® Hourglass

      The TriMark Biopsy Site Marker hourglass shape is for use with the Brevera Breast Biopsy Device, and available in two different gauge sizes. Options available: 9G or 12G, 130mm length.

      TriMark biopsy site markers are small, permanent radiopaque markers placed within the biopsy site during stereotactic 2D or 3D breast biopsy procedure for future identification of the biopsied area. TriMark Biopsy Site Markers are made of biocompatible titanium in 2 distinct shapes; cork and hourglass.

      Reliable and simple, their small size and smooth edges make them optimal for superficial lesions or for lesions close to the chest wall. All TriMark biopsy site markers include the deployment device and biopsy site marker for marking an open or percutaneous biopsy site.

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      Working with Brevera

      The Ultimate Combination

      Over 90% of patients agreed that their biopsy procedure was faster and more comfortable than expected when using the Brevera Breast Biopsy System in combination with the Affirm® Prone Breast Biopsy System.10

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      Patient using breast biopsy system with healthcare professional

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      Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

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        References
        1. Hologic Data on File: VAR-05326, Rev 2
        2. Hologic Data on File: MISC-07678-EUR-EN, Rev 1
        3. Hologic Data on File: MISC-07662-EUR-EN, Rev 1
        4. Hologic Data on File: DHM-06042, Rev 1
        5. Hologic Data on File: MISC-07876, Rev 1, attachment 2
        6. Tumark® Marker Data Collection Study, 2017, DHM-06169, Rev 1, 3 clinicians at 3 hospitals for 90 marker placements, 2017
        7. Hologic Data on File: VER-07555, Rev 001
        8. Yen P, Dumas S, Albert A, et al. Post-Vacuum-Assisted Stereotactic Core Biopsy Clip Displacement: A Comparison Between Commercially Available Clips and Surgical Clip. Can Assoc Radiol J. 2018 Feb;69(1):10-15. doi: 10.1016/j.carj.2017.08.004. PMID: 29458952. Devices show reduced displacement when compared to traditional metal surgical clips (28% and 27% vs 38% displacement, p = 0.001 and p = 0.0001). Visibility is dependent on surrounding tissue, experience may vary.
        9. Pinkney DM, Shah BA. Prospective Comparative Study to Evaluate the Sonographic Visibility of Five Commercially Available Breast Biopsy Markers. Journal of Diagnostic Medical Sonography. 2013;29(4):151-158. doi:10.1177/8756479313486962. *45.4 % of respondence rated SecurMark high sonographic visibility after 6-weeks post procedure, 4x more than the Gel Mark UltraCor™
        10. Hologic data on file. CSR-00127, Rev 1
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