Mammotome Biopsy System

Trust 4 Million Mammotome Biopsies

Patients and Physicians Trust Mammotome

The Mammotome® Biopsy System has been helping physicians accurately diagnose breast cancer since 1995. No other vacuum-assisted breast biopsy device can match:

• Clinical Preference: Over 4 million biopsies performed
• Research-referenced in more than 200 clinical articles
• Fifteen Years of Trust: Mammotome has continued to refine its products to meet our customers' clinical and professional needs

Mammotome Facts

• More than 4 million women have had successful breast biopsies using the Mammotome Biopsy System worldwide since 1995.
• The Mammotome Biopsy System is offered in approximately 2,500 hospitals, breast centers and physician offices.
• Breast biopsies using the Mammotome Biopsy System can be performed in an outpatient setting or doctor's office under local anesthesia.
• Patients can return to normal daily activity immediately following a breast biopsy using the Mammotome Biopsy System.
• Approximately 95% to 99% of all health insurance plans cover breast biopsies using the Mammotome Biopsy System.
• The Mammotome Biopsy System can be used to biopsy breast abnormalities in x-ray, ultrasound, MRI and molecular imaging modalities.
• Tissue samples collected using the Mammotome Biopsy System are as reliable as open surgical biopsies, and more accurate than core needle biopsies in the diagnosis of conditions associated with early breast cancer.
• The Mammotome Biopsy System is suitable for sampling breast abnormalities including microcalcifications, spiculated masses, asymmetric densities, multifocal disease and diffuse tissue.
• In 2003, the Mammotome Biopsy System also received clearance for fibroadenomas (non-cancerous breast lumps). Millions of women can now receive care in a doctor's office with the Mammotome Biopsy System rather than having the lump removed by invasive surgery in an operating room.

Advantages

A breast biopsy using the Mammotome Biopsy System can help a doctor make a highly accurate diagnosis of a breast abnormality without the need for open surgery. The Mammotome Biopsy System can also be used for a non-cancerous breast lump such as a fibroadenoma. A lump may be reduced in size at the same time it is biopsied, often to the point where the lump may no longer be seen under ultrasound or felt during self examination.

Risks and complications

The Mammotome Biopsy System is for diagnostic use only and is not indicated for therapeutic use. Use of the Mammotome instruments is contraindicated for those patients where increased risk or complications may be associated with core removal or biopsy based upon the physician's judgment. Patients receiving anticoagulant therapy or who may have bleeding disorders may be at increased risk. As with any breast biopsy procedure, a breast biopsy with the Mammotome Biopsy System may present risks. Patients should consult with their doctors to discuss which type of breast biopsy procedure is appropriate for them.

How it works

Through the use of imaging methods such as X-ray or ultrasound, a breast abnormality or breast lump can be detected, even in its earliest stages. Using the same imaging methods, a physician can guide a Mammotome probe into a suspicious area of the breast to gently collect the abnormal tissue through one small, ¼-inch incision.

With the Mammotome Biopsy System, a breast biopsy can be performed in an outpatient setting under local anesthesia. A doctor can make a precise analysis with minimal pain, scarring and recovery time. The biopsy procedure takes less than an hour, and patients can return to their normal daily activities immediately.

The Mammotome Biopsy System also can be used for fibroadenomas (non-cancerous breast lumps). Millions of women can now receive care in a doctor's office with the Mammotome Biopsy System rather than having the lump removed by invasive surgery in an operating room.

Since the Mammotome Biopsy System can be used for non-cancerous breast lumps, women now have an option other than open surgery when facing a fibroadenoma.

Indications for use

The Mammotome® Biopsy System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The Mammotome Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Mammotome Platform

Standardized system with customizable features

The Mammotome® Biopsy System Control Module with SmartVac® simplifies the biopsy procedure using single insertion technology with vacuum assistance for the partial or complete removal of an imaged abnormality through a suture less incision. Use of a single incision, single insertion and single probe makes the Mammotome Biopsy System a reliable diagnostic alternative to open surgical biopsy.

The Mammotome Biopsy System enables breast biopsies to be performed in
Stereotactic (x-ray), Ultrasound and MRI imaging modalities using the same Control Module.

The key benefits of the Mammotome Biopsy System platform are

• Designed to maximize tissue quality and diagnostic accuracy
• Software-driven and upgradeable system to keep up with the changing needs of physicians and patients
• Holster (driver) and probes (needles) have customized features to satisfy the variegated needs of breast biopsy in the three different imaging modalities

As a result, physicians can offer an accurate diagnosis without the complications of an open surgical biopsy and without the multiple insertions required with other biopsy devices.

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