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Breast Biopsy Device and Accessory Vendors (VAB and excisional devices)
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VENDOR
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PRODUCT NAME & DEVICE CATEGORY
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SPECIFICATIONS
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REGULATORY STATUS
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COMMERCIAL STATUS
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LIST PRICE
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Ethicon Endo-Surgery
Cincinnati, OH
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Mammotome -- VAB
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Vacuum-assisted breast biopsy under stereotactic or ultrasound guidance.
Probe is inserted through an incision in breast. Device vacuums, cuts, and removes tissue samples for evaluation. Samples are passed through hollow chamber of probe into a collection chamber.
Multiple specimens can be collected without having to remove and reinsert the device.
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Cleared 1996; handheld device cleared in 1999.
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In use at estimated 1,600 hospitals, breast centers, and physician offices.
Nearly 99% of all health insurance plans cover breast biopsies using Mammotome system.
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$10,000 (estimate)
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Suros Surgical Systems
Indianapolis, IN
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ATEC (Automated Tissue Excision and Collection) -- VAB
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Vacuum-assisted breast biopsy using stereotactic, ultrasound, or MRI guidance.
Completely disposable hand piece, tubing set, and needle.
Uses 9- or 12-gauge needle.
Handheld, air-powered system collects tissue at a rate of 16 cores per minute.
Tissue is excised, retrieved, and collected by activating foot pedal.
Pre-assembled hand piece, tubing set, and blade designed for single-patient use.
Closed system provides minimal fluid exposure and no handling of individual core samples.
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Cleared March 2002 for diagnostic breast biopsy.
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In use in 15 states.
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"Comparable" to competitors, according to company, in terms of capital cost; disposables component costs more than other VAB disposable components.
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U.S. Surgical
Norwalk, CT
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Minimally Invasive Breast Biopsy (MIBB) -- VAB
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Vacuum-assisted breast biopsy
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Cleared in December 1997
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Available
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N/A
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Sanarus Medical
Pleasanton, CA
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Centrica Rotational Core Biopsy System -- large-core needle
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Rotational ultrasound-guided breast biopsy system.
19-gauge needle, 10-gauge cutting cannula is introduced through 3-4 mm incision.
After needle insertion, foot pedal-activated system uses inert argon gas as cooling agent to "stick freeze" lesion. Tissue surrounding the needle is adhered; cutting cannula rotates and advances automatically over the needle and cores specimen. Device is removed with affixed specimen; cannula retracts and deposits core into specimen container.
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Cleared in November 2001
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Available in U.S.
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$4,950; disposable component $225
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Imagyn Medical
Irvine, CA |
SiteSelect -- large-core needle
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Large core stereotactic-guided breast biopsy.
22-mm system allows for single, large-core specimen retrieval.
Available in 10-mm, 15-mm, and 22-mm systems.
Keeps tissue intact between skin and lesion; samples lesion only.
Uses circumferential action, no motors or cautery.
Ability to remove entire lesion, no motors or vacuum.
Field-block anesthesia is administered in four positions. Localizing needle is advanced into lesion and stabilized with hook wire. A 15-16 mm skin incision is performed with an 11-blade scalpel. The SiteSelect device is advanced to the lesion and target area. The snare wire cuts the distal end of the specimen after cannula advancement. The SiteSelect device, with the specimen inside the cannula, is removed from the breast.
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22-mm system cleared in September 2001; earlier clearances were for 10-mm and 15-mm devices.
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Available
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N/A
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U.S. Surgical
Norwalk, CT
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Advanced Breast Biopsy Instrumentation (ABBI) -- large-core needle
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Large-core stereotactic-guided breast biopsy.
Device allows for large specimen sample, from 5 mm to 20 mm of tissue, or total lesion excision.
Guide wire is placed under stereotactic guidance; cannula is inserted and specimen removed with looped wire.
System places wire marker in the breast and removes tissue sample in single step.
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Cleared for diagnostic breast biopsy only (1997)
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Available
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N/A
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InRad
Kentwood, MI
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UltraClip -- accessory
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3-mm steel tissue marker for breast biopsy follow-up.
Visible with mammography and ultrasound.
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Available
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N/A
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Artemis Medical
Hayward, CA
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Mammomark --accessory
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Collagen-based self-expanding breast biopsy marker with titanium clip.
After placement, hydrates, conforms to size and shape of biopsy cavity, can be visualized mammographically and on ultrasound.
Resorbs within weeks, leaving clip for long-term follow-up.
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Cleared February 2002
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Available
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N/A
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SenoRx
Aliso Viejo, CA
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Gel Mark -- accessory
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Gelatin-based biopsy site marker visualized using ultrasound, mammography, and digital mammography.
Compatible with Mammotome and MIBB.
Disposable device releases gelatin pellets that hydrate and swell within the biopsy cavity, resorbing within a few weeks.
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Cleared March 2000
Gel Mark Ultra, which remains visible on ultrasound for up to six weeks and dispenses a steel marker for permanent mammographic visualization, cleared July 2001.
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Gel Mark available; Gel Mark Ultra in beta site evaluation.
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N/A
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SenoRx
Aliso Viejo, CA
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EasyGuide -- accessory
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Radiofrequency-based introducer sheath for minimally invasive breast biopsy.
Use with handheld biopsy devices under ultrasound guidance.
Provides a "working port" for biopsy probes into all types of breast tissue.
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Cleared January 2001
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N/A
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Ethicon Endo-Surgery
Cincinnati, OH
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MicroMark II -- accessory
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Tissue marker for postoperative breast biopsy monitoring.
Undetectable to patient, allows physician to keep track of an abnormality in future mammograms.
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N/A
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Available
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N/A
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UltraGuide
Lakewood, CO
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UltraGuide 1000 -- accessory
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Electronic visual aid for freehand ultrasound-guided breast biopsies.
Assists in targeting lesions.
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N/A
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N/A
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N/A
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MRI Devices Corporation
Waukesha, WI
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Immobilization and biopsy positioning device for MR appplications
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Works with the company's open breast array coil.
Medial and lateral compression plates immobilize breast tissue for the procedure. Procedure is performed without changing the position of the patient in the coil or biopsy device.
After the lesion is localized under MR guidance, a titanium hook localization wire may be placed for follow-up surgical biopsy. Alternatively, a low-artifact titanium coaxial needle may be placed to use as a guide for taking samples with MR-compatible semi or fully automatic biopsy gun.
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Breast biopsy device FDA cleared April 2001.
Interventional instruments FDA cleared March 2001.
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Hundreds sold worldwide.
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Breast biopsy device -- $12,500
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