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Published on 5/22/2006 in the Prospect News Biotech Daily.

Medtronic plans pivotal trials of treatments for overactive bladder, enlarged prostate

By Lisa Kerner

Erie, Pa., May 22 - Medtronic, Inc. said it plans two separate post-market pivotal trials of its commercially available urological therapies, InterStim Therapy for Urinary Control for overactive bladder and urinary retention, and Prostiva RF Therapy for symptomatic benign prostatic hyperplasia (BPH).

The company made the announcement at the American Urological Association meeting in Atlanta.

"Clinical trials that establish class 1 evidence (demonstrating substantial benefit vs. risk) pave the way for most treatments that are recognized as standards of care," urological therapies division president Richard E. Kuntz said in a company news release.

"With that notion in mind, we intend to initiate two separate clinical trials - one for InterStim Therapy; the other for Prostiva RF Therapy - within the next year in order to drive each therapy in that direction."

InterStim Therapy for Urinary Control uses sacral nerve stimulation to improve bladder function. According to Medtronic, overactive bladder affects 33 million people in the United States.

Prostiva RF Therapy delivers low-level radio frequency energy through the urethra, destroying a defined region of the enlarged prostate and improving urine flow in patients with BPH. The urological condition affects more than 50% of men over age 50 and 80% of men over age 80.

Medtronic is a medical technology company based in Minneapolis.


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