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Eviva® Breast Biopsy System

Designed with enhanced technology, the system combines optimised patient access with seamless integration for a compassionate, minimally invasive breast biopsy.

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    Overview

    Taking Breast Biopsy to a Higher Standard

    The Eviva Breast Biopsy System was designed with the flagship technology of the Hologic ATEC® Breast Biopsy Device, with additional features for optimal use during stereotactic or 3D biopsy procedures. Listening to physicians and technologists about the women they treat is the foundation for the device’s innovative design. Breast biopsies using Eviva provides clinicians with high quality core samples.1

    All Eviva Breast Biopsy Systems work with the ATEC Breast Biopsy System. Stereotactic kits are also available for use with competitive systems.

    Trusted Globally

    Proven technology designed to deliver a fast, compassionate, and easy breast biopsy.5

    Fast & Easy

    Remove consistent cores in under 30 seconds with 4.5 second biopsy cycle time.2

    Easy set up and clean up.

    Optimise access to challenging lesions close to the chest wall using a low-profile needle.

    Manage thin breast compressions as small as 19mm.3

    Compassionate

    Manage patient pain by automatically applying local anaesthetic directly to the biopsy site with every core, via the patented Y-valve.4

    Minimises complications and maximises patient satisfaction.5

    Quiet, remote firing for greater physician-patient interaction.5

    Patient Access

    Optimised access to challenging lesions.

    Biopsy needle options for most breast sizes.

    Saline lavage and constant aspiration to assist in consistent core retrieval, and to minimise pain and bleeding.

    Seamless Integration

    One unified system for biopsy and site marking.

    Easily delivers local anaesthetic directly to the biopsy site during every cycle without interruption.

    No software required to program or operate the console.

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

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    Illustration of Hologic Breast Health Continuum of Care with Radiology

    Improved Patient Experience

    When it comes to what’s important, 9 out of 10 clinicians agree the Eviva device offers a better patient experience compared to other vacuum assisted breast biopsy devices.5

    Acquires high quality core samples

    Minimises complications and maximises patient satisfaction

    Easy-to-operate

    Breast biopsy device and needle

    Eviva Breast Biopsy Family of Devices

    With its multiple 9G and 12G needle options, the Eviva breast biopsy system enables access to more patients. 

    • Standard Eviva Biopsy Device: 9 or 12 gauge, 10 or 13 cm length, 20 mm aperture, 23 mm throw/stroke
    • Trocar Petite Eviva Biopsy Device (for min compression of 20 mm): 9 gauge, 10 or 13 cm length, 12 mm aperture, 15 mm throw/stroke
    • Blunt Nose Petite Eviva Biopsy Device (hemispherical tip, for min compression of 19mm): 9 gauge, 10 or 13 cm length, 12 mm aperture

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    Patient visiting Breast Biopsy Suite

    A Comprehensive Range of Compatible Breast Biopsy Markers

    The Hologic range of biopsy site markers for use with the Eviva 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 Eviva 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, 129.5mm  or 133mm 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.7 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.8

    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 MRI 
    • The mesh structure in a 3D spherical design leads to high echogenicity in ultrasound imaging regardless of transducer positions7
    • Markers expand into shapes upon deployment and anchor firmly in the tissue7
    • 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 Eviva Breast Biopsy Device, and available in both petite and standard size. The Q-shape becomes firmly anchored in the tissue.7 The slightly open, spiral-shaped design, sandblasted and twisted material designed to provide visibility in ultrasound.6 Options available: 18G, 132mm  or 135.5mm 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.7 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.8

    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 tissue7
    • Intelligent design provides tissue fixation7
    • 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 on white background

    Tumark® Professional X

    The Tumark Biopsy Site Marker is for use with the Eviva Breast Biopsy Device, and available in both petit and standard size. Lateral anchor “feet” provide secure anchoring in the tissue7 and the marker is twisted shape with angled ends. Options available: 18G, 129.5mm  or 133mm 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. The ergonomic handle design allows for single-handed use under ultrasound-guidance.

    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 of the markers provides long-term visibility in ultrasound, X-ray and MRI7
    • Markers expand into shapes upon deployment and anchor firmly in the tissue7
    • Ergonomic delivery device handles allow for single-handed use
    Biopsy site marker on white background

    SecurMark® Mini Cork

    The SecurMark Breast Biopsy Marker is for use with the Eviva 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, in 100mm or 130mm length.

     

    SecurMark Biopsy Site Markers are designed to minimise movement within the biopsy cavity.9 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.10 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 Eviva Breast Biopsy Device, Mini Cork and Top Hat. Additional lengths options are available for use with ATEC® Breast Biopsy Device.

    Top hat biopsy site marker on white background

    SecurMark® Top Hat

    The SecurMark Breast Biopsy Marker is for use with the Eviva 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, in 100mm or 130mm length.

     

    SecurMark Biopsy Site Markers are designed to minimise movement within the biopsy cavity,9 allowing for high sonographic visibility even at  6 weeks* post procedure.10 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 Eviva Breast Biopsy Device, Mini Cork and Top Hat. Additional lengths options are available for use with Brevera Breast Biopsy Device and  ATEC Breast Biopsy Device.

    Cork biopsy site marker on white background

    TriMark® Cork

    The TriMark Biopsy Site Marker is for use with the Eviva Breast Biopsy Device, and available in two different lengths and gauge sizes. Options available: 9G in 100mm or 130mm length, 12G in 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 on white background

    TriMark® Hourglass

    The TriMark Biopsy Site Marker is for use with the Eviva Breast Biopsy Device, and available in two different lengths and gauge sizes. Options available: 9G in 100mm or 130mm length, 12G in 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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    Video Gallery

    3D Breast Biopsy Procedure with Eviva Breast Biopsy Device

    Eviva upright stereotactic biopsy with Affirm®

    ATEC console set up with Eviva

    Patient Experience in Stereotactic & 3D Breast Biopsy

    Because Hologic recognises the anxiety women have when facing a breast biopsy, we are committed to focusing on creating a better patient experience with the products we provide. Eviva was designed for use with the advanced prone and upright Affirm™ Breast Biopsy Guidance Systems, offering optimised access.

    • With the ability to biopsy to a minimum breast compression of 19mm, Eviva gives more women an alternative to open surgical biopsy.3
    • It also offers patients a positive cosmetic outcome post-biopsy, with maximised core retrieval and minimal incision size.5
    Patient speaking with healthcare professional

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      References
      1. Hologic Data On File: MISC-06068, Rev 001. 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
      2. Hologic data on file, VER-03567, Rev 001
      3. Hologic data on file, VER-05759, VER-04202, VER-04111, VER-03205, VER-03792, DHM-02115, DHM-02203.
      4. Hologic data on file, AW-02708 - Instructions for use - Eviva - Stereotactic guided breast biopsy system.
      5. Hologic data on file, MISC-06068, Attachment 1 Kadence study, “Eviva Audit – Identifying optimal claims for the Eviva Breast Biopsy device”, July 2015.
      6. Tumark® Marker Data Collection Study, 2017, DHM-06169, 3 clinicians at 3 hospitals for 90 marker placements, 2017.
      7. Hologic Data on File: MISC-07876, Rev 001 attachment 2
      8. Hologic Data on File: VER-07555, Rev 001
      9. 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.
      10. 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™
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