Breast Tissue Ablation Device: The FDA has approved Cryocare Surgical System....
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 with fibroadenoma for whom 6-month follow-up data are available, seven demonstrated no evidence of the fibroadenoma, six had a 55% average reduction in tumor volume, and for three the margins were not discernible by ultrasound. Both patients with fibroadenoma for whom only 3-month follow-up is available had an average tumor volume reduction of 59%.
No serious adverse events were reported. Three patients had greater than anticipated pain but none required narcotic medication, and two had minor skin dimpling. Four patients had a temporary increase in cryolesion and/or fibroadenoma volume 6 weeks to 6 months after the procedure.
Published on 11 January 2002