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Tined Lead For Interstim Therapy Enables Percutaneous Implant

Available in north america and europe starting in october, newly designed lead for sacral nerve stimulation may shorten procedure and recovery times

MINNEAPOLIS –– Oct. 2, 2002 –– InterStim® Therapy for Urinary Control, which uses an implanted medical device akin to a cardiac pacemaker to stimulate the sacral nerves and improve bladder function, will become better for physicians and patients this month with the full-scale commercial launch in North America and Europe of a new lead that can be implanted percutaneously.

Developed by Medtronic, Inc. (NYSE: MDT), the new lead features tines, which eliminate the need for suturing and help keep the lead in place. It also may shorten the time required for implant and facilitate faster patient recovery as a result of less muscle trauma and a minimized surgical incision. Other features of the tined lead include visual, tactile and fluoroscopic markers that aid in proper placement.

“The tined lead represents a significant improvement in InterStim Therapy for Urinary Control,” according to Dr. Magdy Hassouna, a urologist at Toronto Western Hospital in Ontario and a participant in the physician evaluation of the newly designed lead for sacral nerve stimulation. “It simplifies the implant procedure, which can now be performed percutaneously and, as a result, with only local anesthesia. Most importantly, the tined lead holds. In my experience, I have observed no lead migrations through six weeks post-implant.”

The physician evaluation of the tined lead began in June as part of a limited market release in Europe and Canada; eight urologists and 20 patients with urinary control problems participated. Commercially available to physicians in Canada and Europe starting today and in the United States beginning Oct. 7, the tined lead received CE Mark approval in April and FDA approval in September.

As many as 20 million Americans suffer from bladder control problems, and the vast majority –– about 85 percent –– are women between the ages of 30 and 59. Before the introduction of InterStim Therapy in the late 1990s, treatment options for these problems were limited to medication, biofeedback and pelvic floor exercises at the start of the care continuum, and irreversible surgical procedures such as bladder augmentation, bladder removals and urinary diversions at the end. Medtronic estimates that tens of thousands of properly selected patients could benefit from InterStim Therapy, a viable treatment option in the middle of the care continuum.

InterStim Therapy is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urge incontinence and significant symptoms of urgency-frequency, alone or in combination, in patients who have failed or could not tolerate more conservative treatments. It received FDA approval in September 1997 as a treatment for urinary urge incontinence and in April 1999 for significant symptoms of urgency-frequency and nonobstructive urinary retention.

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 InterStim Therapy is available online at www.interstim.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 Medtronic’s Annual Report on Form 10-K for the year ended April 26, 2002. Actual results may differ materially from anticipated results.

Contact:


Joe McGrath, Public Relations, 763-505-2634


Kevin Lee, Investor Relations, 763-505-2695


 


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