Enlarged Prostate

FDA approval granted for Prolieve Thermodilatation system

Published in Medical Letter on the CDC and FDA, March 21st, 2004

Celsion Corp. (CLN) announced that the U.S. Food and Drug Administration (FDA) has approved its Prolieve Thermodilatation system for the treatment of the symptoms of Benign Prostatic Hyperplasia (BPH) a condition affecting older men more commonly referred to as an enlarged prostate.

The system is a dual action technology (thermodilatation), employing heat and urethral dilatation to provide significant symptomatic improvement in 2 weeks. This device is used in an in-office procedure that minimizes patient discomfort and the need for post-treatment catheterization.

In a randomized 1-year clinical trial, conducted at 14 centers across the United States,...

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Source: Medical Letter on the CDC and FDA (2004-03-21)

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