Edap Technomed.
This article was originally published in The Gray Sheet
Executive Summary
Investigational device exemption is slated for submission by the end of the second quarter for the Ablatherm high-intensity focused ultrasound system for the treatment of prostate cancer. Edap's proposed clinical trial protocol would study patients not responsive to radiation therapy. Ablatherm uses high-temperature ultrasound delivered via a rectal probe to ablate cancerous prostate cells. The firm also has a premarket approval application supplement pending with the agency for a "compact version" of its Prostatron transurethral microwave thermotherapy treatment for benign prostate hyperplasia. The device will be sold to smaller hospitals and to the urology office market at a reduced price compared to current versions of the system. Bard's Urological Division, which co-markets the current Prostatron line, also will co-market the compact system...
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