INDIGO MEDICAL INITIATES CLINICALS OF SOLID STATE LASER FOR BPH
This article was originally published in The Gray Sheet
Executive SummaryINDIGO MEDICAL INITIATES CLINICALS OF SOLID STATE LASER FOR BPH, the firm announced at the recent American Urological Association meeting in San Francisco. The initial human clinical trials of the company's galliumaluminum-arsenide laser for the treatment of benign prostatic hyperplasia are being conducted at Lovelace Medical Center, Albuquerque, New Mexico. Under the firm's investigational device exemption, FDA has requested thermometry data from an initial 15-patient cohort before approving larger, multi-center trials, which the firm anticipates will commence in September and involve 150-200 patients at six to eight centers in the U.S.
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