Ultasound is the use of high-frequency sound waves to penetrate the tissue and allow more precise observation of any abnormalities in the breast.

Ultasound is completely safe and there is no radiation exposure. This Diagnostic tool is particularly helpful in determining whether a lesion or lump is solid or a cyst (filled with fluid). This determination, once made, allows for a more accurate diagnosis and treatment regimen.

Dr. Gerhart uses state-of-the-art Hitachi Model EUB405 for Ultrasound purposes. This Model is equipped with a 7.5MHz probe specifically designed to give clear pictures of the breast.

If a cyst (fluid-filled sac) is found, Dr. Gerhart uses the ultrasound as a guide in removing the cyste fluid. Afterwards, the ultrasound exam allows him to determine if the cyst is completely emptied. The test can also be repeated in a few weeks to determine whether the cyst has refilled again.

If a lump is found, Dr. Gerhart can use the ultrasound as a guide in doing a needle biopsy under local anesthesia right in the office. This may prevent the need for a biopsy to be done at the hospital.

The use of ultrasound-guided Aspiration and Biopsy has many advantages for the patient:

• Accurate diagnosis of breast lump
• Safe - no radiation exposure
• Convenience - an in-office procedure avaiding a trip to the hospital
• Comfort - local anesthesia without large incisions
• Faster results

Sanarus is in early commercial release of its new Cassi™ Rotational Core Biopsy Device, which is FDA cleared. This new device leapfrogs competitive technology in that it enables radiologists and surgeons to obtain large core breast tissue samples that lead to a more accurate diagnosis, without the burden of capital expenditure. The Cassi Device is easy to use, completely portable and disposable, and provides large contiguous tissue samples, while maintaining the intemal complexity of automation and rotation required for larger reimbursement levels, via CPT code 19103. These product features result in fewer biopsy passes per patient, reduced procedure time, the flexibility to perform biopsies in multiple exam rooms, and favorable reimbursement.

The entire procedure is performed through a 3 mm incision in the breast, which requires only local anesthesia and no sutures. Under ultrasound visualization, a small needle is placed directly into the tissue. Once placement is confirmed via ultrasound, the immobilized lesion is "stick frozen" for a few seconds, which secures the targeted tissue and enables a large tissue sample to be removed for evaluation.

Each year, more than 1.5 million women in the United States require breast biopsies.

The Visica Treatment System, developed by Sanarus Medical, Inc. is a minimally invasive, office-based procedure that uses cryoablation technology to treat fibroadenomas (benign breast tumors). Cryoablation is designed to destroy targeted tissue through extreme cold. The Visica Treatment System is the only FDA-cleared ablation therapy for fibroadenomas. The procedure enables women to bypass the operating room and general anesthesia, opting instead for a 20-30 minute procedure performed in their surgeon's office using ultrasound guidance.

This year an estimated 1.3 million biopsies will be performed for breast tumors. While cancer is the most well known form of breast disease, approximately 80 percent of breast tumors are diagnosed benign. The most common form of benign breast tumors is fibroadenoma. This benign breast condition can cause pain, disfigurement and lead to psychological distress. Currently the only treatment option for removal of fibroadenoma is open surgical excision. Open surgery for benign tumors typically involves a day in the hospital, general anesthesia, stitches, and 2-3 days of recovery. In contrast, the Visica Treatment System is an office-based procedure that involves placing a small needle (about the width of a matchstick) into the center of the tumor using ultrasound guidance. Through the needle, the surgeon applies extreme cold to freeze and destroy the tumor, a process called cryoablation. The "iceball" that encompasses and kills the tumor is very easy-to-see with ultrasound. Since the treatment is performed under local anesthesia, patients remain conscious throughout the procedure. Over the subsequent three to twelve months, the tumors progressively shrink and disappear. The Visica Treatment System has been successfully utilized in more than 50 sites in the U.S. and Brazil. Physicians using the Visica Treatment System found the procedure to offer several advantages over open surgery, including no stitches, less scarring, local anesthesia and increased patient comfort. Additionally, due to the inherent anesthetic property of cryoablation, or freezing, the procedure creates little or no pain.

Visica Case Video (2.3Mb): Macromedia Flash player is required to view this video. Download it here.
Visica Animation (1.7Mb): Macromedia Flash player is required to view this video. Download it here.

What is Sentinel Lymph Node Biopsy?

SLN biopsy is a new technique designed to identify breast cancer metastasis in the lymph nodes under the armpit without removing all of the lymph nodes. A radioactive dye is injected into the area of the primary tumor in the breast. The body's natural fluids take the dye through the lymphatic fluid to the lymph nodes. The dye is trapped in the first lymph node, which is called the "sentinel" lymph node that is the sentinel or "guard" lymph node for the armpit. The assumption is that the first lymph node to receive the dye should also be the first lymph node to receive cancer cells. Whether or not removing only this lymph node is enough to determine if cancer is present in the remainder of the axilla is the subject of the current research program.

Sentinel Lymph Node Research Project

The research project currently being undertaken involves biopsying the SLN in women with breast cancer. These women will also then have the remainder of the axillary lymph nodes removed, which is currently the standard treatment of breast cancer. The biopsy results from the SLN and the remainder of the axillary nodes will then be compared. The results will be studied to see if cancer in the axillary lymph nodes will be accurately diagnose with removal of only the sentinel lymph node.

Risks of the Procedure

The research project currently being undertaken involves biopsying the SLN in women with breast cancer. These There are two types of dye used for the procedure. One is Technetium 99 labeled Sulfur Colloid, which is a radioactive dye that is detected by a radiation sensor, called the Navigator probe. The second dye is Lymphazurin Blue, which is a blue dye that can be visualized with the eyes. The amount of radiation received from the radioactive dye is very small, equivalent approximately to the exposure of radioactivity received when undergoing an x-ray of the abdomen. No lead shielding is needed by the patient or the staff working with the patient because the dose of radiation is so small. There is a very small risk of allergic reaction to the radioactive or the blue dye. The blue dye may also cause staining of the skin at the injection site called "tattooing." It can also turn urine blue/green color for several days. In rare instances, the tone of the patient's skin may also acquire a slightly blue hue for a few days.

No additional risk is added to the surgical procedure itself by adding sentinel lymph node biopsy. The lymph node that is identified as the sentinel lymph node by the dye procedures is one of the axillary lymph nodes that would be removed in the standard lymph node dissection. The only difference is that itis being separated from the remainder of the lymph nodes to be evaluated separately.