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Bernard A. Schwetz, DVM,PhD

JAMA. 2002;287:33.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Of the 19 patients with fibroadenoma for whom 12-month follow-up is available, 14 showed no evidence of the fibroadenoma and five had a 79% average reduction in tumor volume. Of the 16 patients . . . [Full Text of this Article]

Acting Principal Deputy Commissioner
Food and Drug Administration