Medtronic Showcases Expanded Urology Product Line Amid Scientific Presentations On Its Established Therapies.

Business Editors & Health/Medical Writers

ORLANDO, Fla.--(BW HealthWire)--May 28, 2002

New offerings include minimally invasive treatment

for BPH and advanced urodynamics system

Medtronic, Inc. (NYSE:MDT), continued showcasing its expanded product line for urology today at the 97th Annual Meeting of the American Urological Association (AUA) while physicians present more data to their colleagues about the company's therapies for benign prostatic hyperplasia (BPH) and voiding dysfunction.

Amid the world's largest gathering of urologists, Medtronic unveiled the new Duet(R) EnCompass urodynamics system to the U.S. market. Previously available only in Europe, the Duet EnCompass is an all-in-one functional diagnostic system that helps urologists diagnose and assess disorders of the lower urinary tract and the colorectal area. The company also introduced TUNA(R) Therapy for the treatment of BPH, often referred to as enlarged prostate. TUNA, which stands for transurethral needle ablation, is a minimally invasive treatment that uses radiofrequency energy to diminish obstructive tissue within the prostate. In addition, Medtronic continues to offer InterStim Therapy for Urinary Control, an innovative treatment for urinary urge incontinence, significant symptoms of urgency frequency and nonobstructive urinary retention that uses an implanted medical device akin to cardiac pacemaker to stimulate the sacral nerves, which influence bladder function.

"Medtronic owes its leadership position in medical technology to our collaboration with thought-leading physicians from around the globe, such as those presenting at this year's AUA meeting," said Martha Goldberg Aronson, vice president and general manager of Medtronic Gastroenterology and Urology. "The new product launches and positive study results for our established therapies presented here today confirm our commitment to being the leading provider of urological disorders."

InterStim(R) Therapy for Urinary Control

In a study to evaluate two techniques employed in the testing phase of InterStim Therapy for Urinary Control, investigators found that the "staged" technique had an 88 percent success rate. The staged technique, which uses a surgically placed lead -- a thin, insulated wire with electrodes at one end -- that can remain implanted if the test result is positive, recently garnered approval from the U.S. Food and Drug Administration as a screening option for patients with a previously inconclusive test stimulation and for whom InterStim Therapy could be a viable treatment. Investigators in this study also found that the risk of reoperation increased in those undergoing permanent implantation under a general anesthetic without assessment of sensory response (43 percent) compared to those implanted under conscious sedation where sensory response was measured (0 percent).

Separately, other researchers offered the results of their evaluation of sacral neuromodulation for refractory interstitial cystitis (IC). IC is an inflammatory bladder process that combines urgency-frequency with pelvic pain. In a multicenter study of 24 individuals with IC, the researchers found that patients whose primary component was "frequency/urgency" responded favorably to sacral neuromodulation with InterStim Therapy, whereas patients who had a significant component of "deep visceral bladder pain" did not demonstrate the same levels of success.

InterStim Therapy for Urinary Control delivers mild electrical impulses to the sacral nerves with an implantable medical device akin to a cardiac pacemaker. The sacral nerves, located in the lower back, influence bladder function. Medtronic developed InterStim Therapy in collaboration with leading urologists and urogynecologists worldwide and first received FDA approval for the device in September 1997 for the treatment of urinary urge incontinence. In April 1999, it was approved to treat significant symptoms of urgency-frequency and nonobstructive urinary retention.

TUNA(R) Therapy for BPH

In the field of benign prostatic hyperplasia (BPH), or enlarged prostate, studies presented at this week's meeting confirmed the long-term efficacy of TUNA(R) (transurethral needle ablation) system, while demonstrating that the procedure is associated with significantly fewer side effects compared with transurethral resection of the prostate (TURP), which currently is considered the surgical standard for BPH.

TUNA is a non-surgical procedure that delivers low-level, precisely controlled, radio frequency energy directly into the prostate to diminish obstructive tissue while protecting the urethra and adjacent structures from harm. BPH affects up to 23 million men worldwide; 50 percent of men over 50, and 80 percent of men over 80, suffer from the progressive and naturally occurring condition that enlarges the prostate gland. The prostate surrounds the urethra and forms part of the male reproductive system. As the gland enlarges with age, it partially closes the urethra and restricts urine flow. This creates significant lifestyle issues, including the frequent and urgent need to urinate, especially at night.

Medtronic added TUNA Therapy to its product line last month when it acquired VidaMed, Inc., the original developer of the technology.

Duet(R) EnCompass System for Urodynamics

Urodynamics is the primary diagnostic procedure for the investigation of the function and dysfunction of the lower urinary tract. Urodynamic testing allows a clinician or researcher to measure how well the bladder stores and empties urine and to identify and differentiate physical and neurological factors involved in bladder disorders. This is important, for example, in the diagnosis of different types of incontinence for which there are various indicated treatments.

The Duet EnCompass system provides urologists optimal diagnostic work-up with a full range of urodynamic testing -- including the gold standard in uroflowmetry, the company's proprietary spinning disk uroflow transducer. The system features logical software that can easily integrate patient information for advanced analysis and reporting. The product also fully integrates fecal disorder diagnostic capabilities, including anorectal manometry with standardized colorectal protocols and advanced neurodiagnostics for pudendal nerve latency studies, free run EMG and various pelvic floor nerve reflex studies.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Medtronic Urology is available online at www.medtronic-urology.com.

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 27, 2001. Actual results may differ materially from anticipated results.