Clinical Study Proves Long-Term Durability of Medtronic TUNA Therapy for Enlarged Prostate.

Business Editors/Health/Medical Writers

MINNEAPOLIS--(BUSINESS WIRE)--Aug. 25, 2003

Minimally-invasive treatment option offers men with benign prostatic

hyperplasia a convenient, effective, one-time procedure that lasts

Results of a multi-center clinical trial reported in European Urology (Vol. 44, pp. 89-93) -- the official journal of the European Association of Urology -- provide new reassurance to men opting for a convenient, long-lasting, office-based treatment for benign prostatic hyperplasia (BPH), or enlarged prostate, when drugs have failed.

Reporting on 188 patients, European physicians presented five-year data showing that the benefit of the TUNA(R) (Transurethral Needle Ablation) Therapy from Medtronic, Inc. (NYSE:MDT), is effective over the long term with low and acceptable failure rates. More than 75 percent of the men treated with TUNA Therapy did not need additional treatment for BPH after five years, according to the researchers.

This new European study supplements results reported at the American Urological Association's (AUA) annual meeting in May 2002 by Dr. Michael J. Naslund, associate professor of urology and director of the Maryland Prostate Center at the University of Maryland in the United States. His team examined the five-year treatment results of a prospective randomized clinical trial that compared TUNA Therapy to transurethral resection of the prostate (TURP), which has long been considered the standard surgical therapy for BPH.

"These long-term results significantly augment an accumulation of safety and efficacy data about TUNA Therapy and should counter any remaining skepticism from the urological community," said Dr. Alexandre Zlotta, a urologist from Erasme Hospital, University Clinics of Brussels, Belgium, and the European study's lead author. "When drugs fail or are not well tolerated for treating voiding difficulties due to enlarged prostate, TUNA Therapy is an effective, minimally-invasive treatment option that deserves consideration as the therapy of choice for success over time."

Conducted at sites in Brussels; Ioannina, Greece; and Haugesund, Norway (no statistical differences reported), patients were evaluated at baseline and five years for urinary peak flow (Qmax), International Prostate Symptom Score (IPSS), post-void residual urine (PVR) and quality of life (QoL).

The study demonstrated: an increase in Qmax from 8.6 milliliters per second to 12.1 ml/s (62 percent of patients achieving an improvement of at least 33 percent); a decrease in IPSSs from 20.9 to 8.7 (78 percent of patients achieving an improvement of at least 50 percent); a decrease in PVR measurements from 179 ml to 122 ml (72 percent achieving an improvement of at least 50 percent); and an increase in QoL of at least 50 percent in 77 percent of patients.

All used earlier generations of TUNA Therapy instrumentation that have now been succeeded by the Medtronic Precision(TM) Plus System, which was introduced in April 2003. The new system reduces treatment time by 25 percent, to about 15 minutes -- depending on prostate size.

The U.S. study demonstrated the long-term safety and efficacy of TUNA Therapy for improving symptoms of BPH and also found that TUNA Therapy resulted in a lower incidence of side effects compared with TURP. Of the men treated with TUNA Therapy, less than 2 percent were impotent and less than 1 percent experienced retrograde ejaculation after one year, compared to 12.7 percent and 38.2 percent respectively among those men who underwent TURP.

Benign prostatic hyperplasia (BPH) affects millions of men worldwide, causing discomfort, inconvenience, interrupted sleep and embarrassment associated with the frequent and sudden need to urinate. Until recently, treatment options were limited to a lifetime of daily medications or surgery.

TUNA Therapy works by delivering low-level radiofrequency energy through a cystoscope inserted into the urethra to destroy obstructive tissue while protecting the urethra and adjacent structures from damage. The procedure is usually performed with the patient under local anesthesia. TUNA Therapy received CE (Conformite europeenne) Mark in 1994, and marketing clearance from the U.S. Food and Drug Administration in 1996.

TUNA Therapy is just one component of the Medtronic suite of technologies for the diagnosis and treatment of urological conditions (www.medtronic-urology.com).

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 25, 2003. Actual results may differ materially from anticipated results.