Healthcare Industry News:  benign prostatic hyperplasia 

Devices Urology

 News Release - May 22, 2006

Medtronic Launches PROSTIVA(TM) RF Therapy System, Proven Treatment Option for Enlarged Prostate

Minimally-Invasive and Cost-Effective Procedure Using Radio Frequency Treats Symptoms of benign prostatic hyperplasia Even Faster and More Safely with Re-Engineered Components

MINNEAPOLIS--(HSMN NewsFeed)--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 (TUNAŽ).

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.

"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 cm(3) and 50 cm(3). 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.

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.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.


Source: Medtronic

Issuer of this News Release is solely responsible for its content.
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