MINNEAPOLIS - May 22, 2006 - Building on the clinically-proven effectiveness of radio frequency (RF) in treating men with the bothersome urinary symptoms of an enlarged prostate gland, Medtronic, Inc. (NYSE: MDT), today announced commercial release of the new PROSTIVA
TM RF Therapy system for the treatment of symptomatic benign prostatic hyperplasia (BPH).
PROSTIVA RF Therapy delivers low-level radio frequency energy through the urethra - now with a re-engineered handpiece and generator - to destroy a precisely targeted area of an enlarged prostate, a common urological condition affecting half of men over age 50 and 80 percent of men over age 80. Approximately 8.4 million American men over age 50 are candidates for treatment of BPH. More than 80,000 men worldwide have been treated for symptomatic BPH with RF therapy. PROSTIVA RF Therapy was formerly called Transurethral Needle Ablation (TUNA©).
In BPH - a non-cancerous enlargement of the prostate that restricts the flow of urine from the bladder (and the most common disorder affecting this male-only gland) - the prostate becomes enlarged to the point that it presses against the urethra like a clamp on a garden hose. Eventually, the bladder weakens and loses the ability to empty. This "clamping" of the urethra and partial emptying of the bladder causes many of the symptoms associated with BPH, which include frequent or urgent urination, leaking or dribbling, and a weak, interrupted, or hesitant urine stream.

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"I choose PROSTIVA RF Therapy for treatment of my patients with BPH because it provides long-term demonstrated efficacy, and avoids the risks and side effects associated with surgical options," said Dr. Marc Milsten of Urologic Specialists of Oklahoma. "It provides the ability for the patient to eliminate the need for long-term use of medications, and it does so in a way that is safe and proven effective."
PROSTIVA RF Therapy is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3. Adverse events associated with RF therapy include obstruction, bleeding, pain or discomfort, urgency to urinate, increased frequency of urination, and urinary tract infection. Patients may also experience a mild burning sensation when urinating for one to two weeks following the treatment.
In contrast to BPH drugs, PROSTIVA RF Therapy is intended as a one-time treatment for symptomatic BPH that improves urine flow and carries a low risk of sexual side-effects. For most men, these improvements start within two to six weeks of treatment and last for at least five years.