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PRESS RELEASE: FDA Approves Medtronic Bilateral `Brain Pacemaker' for Parkinson's Disease January 22, 2004 07:00 AM US Eastern Timezone MINNEAPOLIS--(BUSINESS WIRE)--Jan. 22, 2004--New Kinetra(R) Neurostimulator delivers therapy that previously required two devices; New Access(R) Therapy Controller patient programmer also approved, giving patients enhanced control of therapy American physicians and patients battling the devastating effects of Parkinson's disease learned today of a new treatment option as Medtronic, Inc. (NYSE:MDT), announced U.S. Food and Drug Administration approval of a new device that delivers brain stimulation therapy for Parkinson's disease patients. The new Medtronic Kinetra(R) Neurostimulator, along with its Access(R) Therapy Controller, simplify Activa(R) Therapy for physicians and patients by using one device to deliver Activa Therapy to both sides of the patient's brain. Activa is the only brain stimulation therapy commercially available in the U.S. Device Improves Implant Procedure "Kinetra is now the system of choice for Parkinson's disease because it requires fewer incisions," said Dr. Richard K. Simpson, Jr., professor of neurosurgery at Baylor Medical College in Houston. "Because one Kinetra device can do the work that has previously been done by two devices, surgery duration may be reduced." The new Kinetra neurostimulator is one device that accommodates two Medtronic DBS(TM) leads carrying precisely controlled, electrical impulses to both left and right sides of the brain, thus reducing surgical incisions. Before the Kinetra device, treatment of bilateral symptoms caused by Parkinson's disease required separate implants of two neurostimulators to control some of the disabling symptoms of PD on both sides of the patient's body. Parkinson's Disease and Recent New England Journal of Medicine Article Activa Therapy has evolved as a method of care for Parkinson's when medication alone fails to provide adequate benefit or causes intolerable side effects. Adjustable to best meet the needs of each patient and reversible if necessary, Activa Therapy stimulates structures deep within the brain that influence motor control and appears to block brain signals that cause the stiffness, slowness of movement, and/or shaking that characterize the disease. A recent article in the New England Journal of Medicine reported that, over a five-year period, patients with advanced Parkinson's disease experienced "marked improvements" in motor function and mobility when treated with bilateral deep brain stimulation (DBS). The article reports that compared with baseline measures, at five years, patient scores for motor function (off medication) improved by 54 percent, and scores for activities of daily living improved by 49 percent. It is estimated that about one million Americans suffer from Parkinson's disease, a progressive and degenerative movement disorder that can rob them of their independence. Activa Therapy, commercially launched in the United States for Parkinson's disease in 2002, is the most significant advance in the treatment of Parkinson's in more than 30 years. The cause of Parkinson's is unknown, but the symptoms stem from the degeneration of neurons (brain cells) that produce dopamine. Dopamine is a neurotransmitter that enables communication among the brain cells involved in motor control. Even before the disease is at its worst, patients often experience shaking and flailing (dyskinesias) that rack their bodies and can lead to embarrassment, frustration, and avoidance of public situations. Eventually, the debilitating symptoms of Parkinson's can cause patients to become totally dependent on others for their care. Programmer Streamlines Follow Up Care Medtronic also received approval for its Access Therapy Controller, a "remote control" that enables patients to adjust Activa Therapy stimulation. The convenient hand-held programmer lets patients monitor neurostimulator battery life and fine-tune their stimulation within physician-prescribed parameters. Jon Tremmel, president of Medtronic Neurological said, "Medtronic is committed to maintaining momentum in developing therapies for neurological disorders that have long perplexed physicians and devastated so many lives." Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Additional information about Medtronic, Inc. can be found at http://www.medtronic.com Information about Activa Therapy can be found at http://www.newhopeforparkinsons.com or by calling 1-800-675-5752. News materials, including downloadable still images are available online at http://www.activapresspage.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 25, 2003. Actual results may differ materially from anticipated results. Contacts: Medtronic, Inc., Minneapolis Media Relations: Kathleen Janasz, 763-505-2634 [log in to unmask] or Investor Relations: Rachael Scherer, 763-505-2694 [log in to unmask] SOURCE: Business Wire (press release) http://tinyurl.com/2xnal Reference: MINNEAPOLIS, MN, October 27, 1999 - Medtronic, Inc. (NYSE: MDT), today announced the commercial launch in Europe and Canada of the Medtronic Kinetra™ neurostimulator, which simplifies the delivery of therapy for the debilitating symptoms of Parkinson's disease or Essential Tremor through a single device. http://www.medtronic.com/newsroom/news_19991027080127.html Kinetra Neurostimulator with the Access Therapy Controller http://www.medtronic.com/intl/kinetra2.html * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn