Mammotome Elite Tetherless Vacuum-Assisted Breast Biopsy System
Authorized Mammotome breast biopsy equipment supplier. The Mammotome Elite is the only tetherless vacuum-assisted biopsy system, a cable-free handheld device engineered to provide procedural freedom and diagnostic confidence. By combining the speed of a core needle biopsy with the superior tissue quality of a vacuum system, it lets clinicians manage even the most challenging lesions with ease during ultrasound-guided procedures.
Equipped with integrated TruVac technology and a sharp bladed insertion tip, the Mammotome Elite excels in dense breast tissue and small masses, capturing large, unfragmented samples through single insertion with multiple sampling. Its cordless holster design removes the constraints of traditional consoles, while 10G and 13G echogenic probes, 360 degree needle rotation, multiple biopsy buttons, and a removable coaxial cannula for tissue marker placement keep the ultrasound-guided workflow efficient in any clinical setting.
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Tetherless Design, TruVac Technology, and Single Insertion Sampling
The Elite centers on procedural freedom and tissue quality. A cordless handheld design, integrated TruVac vacuum, and a sharp bladed tip give the team confidence on challenging lesions during ultrasound-guided biopsy. Full technical detail is in the expandable sections below.
Tetherless Cordless Design: a fully cable-free handheld device with an ergonomic holster, charger base, and power cord that removes the constraints of traditional consoles for total procedural freedom
Integrated TruVac Technology: captures and transports large, unfragmented tissue samples from the biopsy site directly to the collection cup
Sharp Bladed Insertion Tip: a bladed tip moves easily through dense tissue, minimizing the time required to navigate to lesions and supporting single insertion
Single Insertion, Multiple Sampling: acquire multiple samples without removing the probe between passes
10G and 13G Probe Options: echogenic probes accommodate a range of biopsy needs, with clear ultrasound visibility for accurate needle placement
360 Degree Needle Rotation: adjust the aperture based on the position of the lesion
Multiple Biopsy Buttons: different button positions allow varied hand positions during sampling to maximize comfort and stability
Introducer Stylet: the compact bladed introducer stylet aligns with the probe tip to help ensure proper aperture placement and maximize control
Removable Coaxial Cannula: facilitates efficient and accurate placement of tissue markers after the biopsy
Three Piece Collection System: a quick release basket expedites tissue removal, a clear cup provides visualization of the tissue, and the design enables touchless transfer to pathology
Ergonomic Holster: a lightweight holster designed for effortless maneuverability during the procedure
Clinical Confidence: the vacuum assist, sharp cutting blade, and small size support more confidence and accuracy in challenging clinical settings
How the Mammotome Elite compares against a traditional tethered vacuum-assisted biopsy console:
The vacuum assist, sharp cutting blade, and small size of the Elite support more confidence and accuracy even in challenging clinical settings. In clinical study comparisons against 14G spring-fired core needle devices, the Elite demonstrated an 83 percent reduction in the underestimation rate, an 11 percent improvement in sampling accuracy, and a 37 percent reduction in the false-negative rate, which gives the surgical team and the patient added confidence in the diagnosis.
Full Technical Specifications
Complete reference data for capital procurement, RFP submissions, and biomedical review. Breast radiologists, pathology teams, and biomedical engineers rely on this specification set when they evaluate a tetherless vacuum-assisted breast biopsy system. Expand each category for full detail.
| Holster | Mammotome Elite Holster (MEH1), includes charger base and power cord, quantity 1 per box |
| 10G Probe | 10G Mammotome Elite Ultrasound Probe (MEP10), quantity 5 per box |
| 13G Probe | 13G Mammotome Elite Ultrasound Probe (MEP13), quantity 5 per box |
| Introducer Stylet | 10G Mammotome Elite Introducer Stylet (MEI10), quantity 5 per box |
| Guidance | Ultrasound-guided procedures |
| Gauge | 10G |
| Needle Diameter | 3.5 mm |
| Needle Length without Coaxial Cannula | 136 mm |
| Needle Length with Coaxial Cannula | 122 mm |
| Aperture Length | 19.1 mm |
| Dead Space | 10.0 mm |
| Tip to Center | 19.6 mm |
| Gauge | 13G |
| Needle Diameter | 2.6 mm |
| Needle Length without Coaxial Cannula | 136 mm |
| Needle Length with Coaxial Cannula | 122 mm |
| Aperture Length | 18.4 mm |
| Dead Space | 10.4 mm |
| Tip to Center | 19.6 mm |
| Introducer Stylet Length | 94.1 mm |
| Introducer Stylet Gauge | 12G |
| Introducer Stylet Diameter | 2.8 mm |
| Coaxial Cannula Length | 91.6 mm |
| Coaxial Cannula Gauge | 9G |
| Coaxial Cannula Diameter | 3.6 mm |
| Vacuum System | Integrated TruVac technology for large, unfragmented samples |
| Insertion Tip | Sharp bladed insertion tip for single insertion |
| Needle Rotation | 360 degree needle rotation to adjust aperture |
| Biopsy Buttons | Multiple biopsy buttons for varied hand positions |
| Collection System | Three piece system with quick release basket and clear visualization cup |
| Tissue Marking | Removable coaxial cannula for tissue marker placement |
Clinical Applications
Deployed across breast biopsy programs where procedural freedom, tissue quality, and a cordless ultrasound-guided workflow decide the confidence of a diagnosis.
The cordless handheld design supports point-of-care ultrasound-guided breast biopsy in clinic and office settings without a tethered console.
A sharp bladed tip and integrated TruVac excel in dense breast tissue and small or vague masses where access and sample quality matter.
A compact device and 360 degree needle rotation help reach and sample masses positioned near the chest wall.
Vacuum assist and large, unfragmented samples support sampling of complex cysts and microcalcifications for a clear diagnosis.
The removable coaxial cannula facilitates efficient and accurate placement of tissue markers immediately after sampling.
A three piece collection system with a quick release basket and clear cup enables touchless transfer of tissue to pathology.
From Cordless Setup to Touch-Free Pathology
A breast biopsy workflow built for procedural freedom and tissue quality. Cordless setup, single insertion targeting, TruVac sampling, and touch-free collection move the case from positioning to a confident diagnosis. Expanded workflow details are in the expandable sections below.
The Elite holster charges on its base station and operates fully cordless, so there is no wall mounted console or vacuum cart to set up. The clinician selects a 10G or 13G echogenic ultrasound probe based on the lesion, and the introducer stylet aligns with the probe tip to help ensure proper aperture placement.
The sharp bladed insertion tip moves easily through dense tissue, minimizing the time required to navigate to the lesion with a single insertion. Clear echogenic ultrasound visibility, 360 degree needle rotation, and multiple biopsy buttons let the clinician adjust the aperture and hand position to confidently target challenging lesions.
Integrated TruVac technology captures and transports large, unfragmented tissue samples from the biopsy site to the collection cup. Single insertion with multiple sampling acquires the desired tissue without removing the probe between passes, which preserves sample quality for pathology.
The three piece collection system uses a quick release basket to expedite tissue removal and a clear cup to visualize the specimen, enabling touchless transfer to pathology. The removable coaxial cannula then facilitates efficient and accurate placement of a tissue marker at the biopsy site for post-biopsy identification.
Regulatory Compliance and Safety
FDA cleared for ultrasound-guided breast biopsy, manufactured by Devicor Medical Products, Inc. Medical Outfitters is an ISO 13485:2016 certified supplier of surgical and imaging equipment, so every Mammotome Elite system ships through a documented and audited quality management system. Full compliance documentation is available in the expandable sections below.
FDA Cleared: the Mammotome Elite tetherless vacuum-assisted breast biopsy system is FDA cleared for ultrasound-guided breast biopsy.
ISO 13485: Medical Outfitters Inc. is independently ISO 13485:2016 certified as a supplier, so every system ships through a fully audited quality management system.
Trademarks: Devicor, Mammotome, and Mammotome Elite are registered trademarks, and TruVac is a trademark, of Devicor Medical Products, Inc.
Regional Availability: the product may not be approved or available in every region, so availability should be confirmed for your location.
Biopsy Site Markers: compatible with Mammotome biopsy site markers including HydroMARK, MammoMARK, CorMARK, MammoSTAR, and LumiMARK, sold separately.
RoHS: Restriction of Hazardous Substances compliant.
REACH: EU REACH chemical regulation compliant.
Procedure & Disposables Review
Tell us your ultrasound-guided biopsy volume and disposables needs. Our team confirms the right configuration of holsters, 10G and 13G probes, introducer stylets, and compatible tissue markers.
Capital Equipment & RFP Support
Pricing, technical documentation, and global logistics for breast biopsy program deployments. We support breast imaging directors, biomedical engineers, and purchasing departments evaluating tetherless biopsy systems. Contact us for RFP packages.
Frequently Asked Questions
Quick answers to the most common purchase and clinical questions about the Mammotome Elite tetherless vacuum-assisted breast biopsy system. Tap any question to expand.
The Mammotome Elite is the only tetherless vacuum-assisted breast biopsy system, a cable-free handheld device for ultrasound-guided procedures. It combines the speed of a core needle biopsy with the tissue quality of a vacuum system, using integrated TruVac technology and a sharp bladed tip to manage challenging lesions in dense breast tissue and small masses.
The Elite is fully cordless and self contained, so it does not connect to a wall mounted console or vacuum cart during the procedure. The ergonomic holster charges on a base station and includes its own power, which removes the constraints of cables and gives the clinician total procedural freedom for a more efficient ultrasound-guided workflow.
Integrated TruVac technology is the vacuum system inside the Elite probe that captures and transports large, unfragmented tissue samples from the biopsy site directly to the collection cup. It supports single insertion with multiple sampling and helps preserve sample quality for pathology.
The Elite offers 10G and 13G echogenic ultrasound probe options to accommodate different biopsy needs. The 10G probe has a 3.5 mm needle diameter and the 13G probe has a 2.6 mm needle diameter, both with a 136 mm needle length and 360 degree needle rotation to adjust the aperture based on the position of the lesion.
The Mammotome Elite is designed for ultrasound-guided biopsy of challenging lesions, including small masses, vague masses, masses near the chest wall, masses in dense breast tissue, complex cysts, and microcalcifications. The vacuum assist, sharp cutting blade, and compact size support accuracy in these difficult clinical settings.
The Elite uses a three piece collection system with a quick release basket that expedites tissue removal and a clear cup that provides visualization of the tissue. The design enables touchless transfer of the specimen to pathology, which reduces manual handling and helps maintain sample integrity.
Yes. The Mammotome Elite tetherless vacuum-assisted breast biopsy system is FDA cleared for ultrasound-guided breast biopsy. Medical Outfitters Inc. is ISO 13485:2016 certified as the supplying distributor, so every system ships through an audited quality management system. Mammotome and TruVac are trademarks of Devicor Medical Products, Inc.
Through Medical Outfitters Inc., ISO 13485:2016 certified, Miami, FL. We supply the Elite holster and 10G and 13G probes with nationwide and global logistics support. Call (305) 885-4045 or request a quote online.
Compatible Equipment
Equipment commonly used alongside the Elite in the breast care pathway, from the Mammotome Revolve dual vacuum-assisted biopsy system and the Mammotome Neoprobe gamma detection system to a Fujifilm mammography platform for detection and localization.
Mammotome Revolve
Dual vacuum-assisted biopsy · stereotactic and ultrasound · 8G and 10G · Mammotome
View Product
Fujifilm Aspire Cristalle
Digital mammography · tomosynthesis · breast imaging · low dose
View Product
Mammotome Neoprobe
Gamma detection · radio-guided surgery · sentinel node biopsy · Mammotome
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