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Cryoablation for the treatment of benign breast disease.

What is benign breast disease? It is estimated that half of all women in the U.S. will seek consultation for a breast disorder in their lifetime. Approximately 80 percent of these women are diagnosed with benign breast disease, defined as any non-cancerous breast abnormality. The most common benign breast tumor is fibroadenoma. Fibroadenomas can grow up to 4 cm, the size of a golf ball, and cause pain, anxiety and disfigurement.

What options are available for women diagnosed with benign breast tumors? Since benign breast tumors will not develop cancerous cells, the majority of women diagnosed with fibroadenomas are told to "watch and wait." Despite this recommendation, the majority of women opt to have their fibroadenoma treated due to uncomfortable physical symptoms and psychological anxiety. Open, excisional surgery previously provided the only option for removal of fibroadenomas. Surgery is still the most common treatment for benign tumors. This procedure involves multiple pre-and post-operative visits, typically an in-hospital procedure that may involve general anesthesia, and 2-3 days of recovery. Surgical excision also leaves scar tissue within the breast.

The Visica® Treatment System marks a breakthrough in treatment of benign breast tumors through an office-based procedure that involves only local anesthesia and no stitches.

What is the Sanarus VisicaÆ Treatment System?
The Sanarus Visica Treatment System is a new office-based treatment offering an alternative to the surgical removal of benign breast tumors. The Visica Treatment System is an ultrasound-guided approach that requires only local anesthesia and is virtually painless. The Visica Treatment System became commercially available for treatment of breast fibroadenoma in October of 2001.

How does the Visica Treatment System work?
The Visica Treatment System freezes and destroys targeted tissue using cryoablation technology, or extreme cold, through a small incision, without requiring stitches or general anesthesia. This procedure is performed in a physician's office and lasts 20-30 minutes. Cryoablation has been shown to be highly useful in destroying common cancers (such as prostate) in long-term studies. In addition, cryoablation is visualized using real-time ultrasound, which helps to provide a controlled and targeted procedure.

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