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From the Food and Drug Administration
January 2, 2002

Breast Tissue Ablation Device

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002American Medical Association

JAMA. 2002;287(1):33. doi:10.1001/jama.287.1.33-JFD10013-2-1

The FDA has approved Cryocare Surgical System (Endocare Inc, Irvine, Calif) for the ablation of benign fibroadenoma of the breast. The software-controlled, microprocessor-operated device has 4 to 8 cryoprobes and uses inert argon gas to cool each distal tip to −180°C. Cryocare had been approved for the destruction of tissue by applying extremely cold temperature to prostate, kidney, and liver metastases, tumors, skin lesions, and warts.

The FDA approval was based on the results of a single-arm, nonrandomized safety and efficacy study of 30 patients with 37 core biopsy– and ultrasound-confirmed fibroadenomas up to 4 cm in diameter. Fibroadenoma volume was measured by ultrasound at 3, 6, and 12 months after the procedure.

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