The growing body of clinical evidence on RF therapy for symptomatic BPH includes 75 published articles in the medical literature. Results of the seminal study - published in the June 2004 issue of the Journal of Urology - "demonstrate stable treatment outcomes after 5 years of follow-up and suggest that TUNA is an attractive treatment option for men with LUTS [lower urinary tract symptoms] due to BPH." The results also showed that only 14 percent of study participants who received RF therapy for BPH had to advance to the main surgical option - transurethral resection of the prostate (TURP) - to relieve their symptoms within five years of treatment with RF therapy. TURP involves the use of a resectoscope inserted into the urethra to cut away enlarged tissues with an electrical loop.
The U.S. Food and Drug Administration granted 510K clearance for PROSTIVA RF Therapy in November 2005. (The document related to the clearance refers to data gathered using any one of several previous models of Medtronic's RF therapy equipment.) Medicare approved the procedure for in-office reimbursement on Jan. 1, 2000.
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