Endocare Receives 510(k) Clearance From FDA to Market Breast Tumor Treatment.(Visica Treatment System)

2001 DEC 6 - (NewsRx.com & NewsRx.net) -- Endocare, Inc., has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market, through its alliance partner, privately held Sanarus Medical, Inc., the Visica Treatment System, for the minimally invasive treatment of fibroadenomas, or benign tumors of the breast.

Sanarus and Endocare operate under a strategic alliance that gives Sanarus license to market Endocare's proprietary cryosurgery and ultrasound guidance technologies for breast therapy applications. Under the alliance Endocare will manufacture the Sanarus device and, largely in return for license to the technology, Endocare maintains a minority equity position in Sanarus.

The Visica device uses targeted cryoablation (the application of extremely cold temperatures to destroy tissue) guided by ultrasound to precisely destroy tumor cells. The entire procedure takes about 20 minutes and can be performed in a physician's office with local anesthesia, without requiring stitches. Most patients can resume normal activities the next day. Benign breast disease causes discomfort and impacts lifestyle for affected women. While cancer is one form of breast disease, approximately 80% of the time lesions are diagnosed benign. The most common form of benign breast tumors are fibroadenomas. The ...