This article was originally published in The Gray Sheet
Cryotherapy surgical system expanded labeling allows for use in targeted ablations of specific portions of a swollen prostate to treat benign prostatic hyperplasia. Endocare reports receipt of 510(k) clearance on April 29 for the indication, which will be assessed through market development studies set to begin in the second quarter. The system, which uses extremely cold temperatures to freeze and destroy selected tissue, was 510(k)-cleared in mid-1995 for ablation of the entire prostate to treat prostate cancer ("The Gray Sheet" June 3, 1996, In Brief)
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