NYSE US 100
05.07.2006 13:00:00
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Medtronic Receives FDA Approval for InterStim(R) II System for Treatment of Overactive Bladder, Urinary Retention
Medtronic, Inc. (NYSE:MDT), today announced that the U.S. Food andDrug Administration (FDA) has approved the company's InterStim(R) IIsystem for the treatment of intractable cases of overactive bladderand urinary retention.
InterStim Therapy for Urinary Control uses sacral nervestimulation to improve bladder function. Originally approved by theFDA in 1997, it is indicated in the United States for the treatment ofnon-obstructive urinary retention and the symptoms of overactivebladder, including urinary urge incontinence and significant symptomsof urgency-frequency alone or in combination, when more conservativetreatments fail or cause intolerable side-effects.
The new system also recently received regulatory approval (CEMark) in Europe, where InterStim Therapy is indicated for themanagement of chronic intractable (functional) disorders of the pelvisand lower urinary tract or intestinal tract, including overactivebladder, urinary retention, fecal incontinence, and constipation.
The InterStim II system adds a new implantable neurostimulator(INS), a new improved patient programmer and upgraded software for theclinician programmer. These advancements offer a choice ofneurostimulation devices to accommodate more patients, streamline theimplant procedure, and simplify programming and follow-up care. Theimproved patient programmer also gives patients more control of theirtherapy.
"This new smaller, lighter device - combined with the array ofsmart design changes to other components of the implantable system -will make InterStim Therapy more attractive to both physicians andpatients," said Dr. Steven W. Siegel, director of MetropolitanUrologic Specialists' Center for Continence Care in St. Paul, Minn."The new patient programmer and physician programmer software upgraderepresent a significant step forward for this treatment option foroveractive bladder and urinary retention. With all of theseenhancements, InterStim Therapy deserves a fresh look from physiciansand patients alike."
The InterStim II system consists of:
InterStim II Implantable Neurostimulator (INS). Ideally suited forpatients with lower energy requirements (as determined during thetherapy trial) or smaller bodies, the InterStim II INS is nearly 50percent smaller by displaced volume and nearly 50 percent lighter byweight than the original device - the InterStim INS, which continuesto be available.
InterStim iCon(TM) Patient Programmer. The InterStim iCon PatientProgrammer offers many new features to improve patient management forphysicians and provide greater therapy control for patients. Patientscan use their InterStim iCon programmer to select from four availableprograms and adjust the stimulation amplitude (only) for each of them.The InterStim iCon programmer offers these new programming features topatients and physicians, regardless of whether they are using theoriginal InterStim INS or the new InterStim II INS.
N'Vision(R) Clinician Programmer. The N'Vision clinicianprogrammer works with all Medtronic neuromodulation therapies. The newsoftware allows the physician to design and track the utilization ofup to four stimulation programs for patients equipped with theInterStim iCon patient programmer. When coupled with the InterStimiCon programmer, the new InterStim software enables improved clinicalmanagement of patient therapy.
Overactive bladder affects 33 million people in the United Statesalone. Worldwide, more than 25,000 people have been treated withInterStim Therapy.
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 theworld.
Any forward-looking statements are subject to risks anduncertainties such as those described in Medtronic's Quarterly Reporton Form 10-Q for the quarter ended January 27, 2006. Actual resultsmay differ materially from anticipated results.
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