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PRESS RELEASE: Medtronic Announces Start of U.S. Pivotal Clinical Trial for Intercept Epilepsy Control System MINNEAPOLIS--(BUSINESS WIRE)--April 13, 2004--Brain stimulation may reduce seizure rates in patients when other therapies are ineffective Medtronic, Inc. (NYSE:MDT), today announced the start of the U.S. pivotal clinical trial for the Intercept(TM) Epilepsy Control System, the company's brain stimulation therapy that may reduce seizure rates in patients with epilepsy. Epilepsy is a condition that affects 2.3 million Americans, and about one-third of these patients continue to experience seizures despite a wide range of treatment options. "Epilepsy remains a devastating disorder for one-third of patients who don't respond to medications, and brain stimulation may offer new hope for people with uncontrolled epilepsy," said Robert Fisher, M.D., Ph.D., professor of neurology and director of Stanford Epilepsy Center, Stanford University, and principal investigator of the clinical trial. "Pilot studies have been encouraging and this clinical trial, if successful, will introduce a welcome new treatment for this unmet medical need." The trial uses existing technology to test whether bilateral stimulation of the anterior nucleus of the thalamus can safely and effectively reduce seizure frequency in patients with epilepsy. It includes 124 patients in a prospective, randomized, double-blind study at 12 sites in the U.S. All patients will be implanted and monitored for 13 months following implant, with long-term follow-up until the device is approved. Patients in the active group, who will receive neurostimulation, will be monitored for a reduction in seizure rates compared to the control group, who will not receive neurostimulation during the double-blind phase. After the double-blind phase, all patients will receive neurostimulation. The therapy is designed to disrupt the circuits suspected of influencing epileptic seizures. The system provides bilateral brain stimulation using three implantable components: a neurostimulator (implanted in the chest), extensions (two small, insulated wires that are threaded from the neurostimulator to the head) and leads (electrodes that are implanted in the thalamus). The neurostimulator generates electrical pulses that are delivered directly to the brain by the extensions and leads. These pulses can be non-invasively adjusted by a clinician from a physician programmer and transmitted via telemetry to the implanted device. In addition to the ongoing stimulation pre-programmed by the physician, patients can activate additional stimulation when they sense an oncoming seizure. Patients activate additional stimulation through a hand-held programmer that resembles a remote control. Candidates for the trial are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. They will have had an average of six or more seizures per month. Candidates will continue to receive their epilepsy medications while participating in the trial. Epilepsy is a neurological condition affecting people of all ages that is characterized by recurring seizures, or brief periods of abnormal electrical activity in the brain. The seizures cause a change in sensation, awareness or behavior. The unpredictability of seizures may affect patients' ability to drive and can disrupt school days, work responsibilities and social activities. Called Medtronic Activa(R) Therapy, brain stimulation therapy already has received approval by the U.S. Food and Drug Administration for Essential Tremor and Parkinson's disease. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Patients can obtain more information about neurostimulation at (www.medtronic.com) or by calling 1-800-510-6735. 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 25, 2003. Actual results may differ materially from anticipated results. Contacts: Medtronic, Inc., Minneapolis Media: Kathleen Janasz, 763-505-2634 [log in to unmask] or Analysts: Rachael Scherer, 763-505-2694 [log in to unmask] At A Glance: Medtronic, Inc. Headquarters: Minneapolis, Minnesota Website: http://www.medtronic.com CEO: Art Collins Employees: 30,000 Ticker : MDT (NYSE) Revenues : $7.665 billion for FY03 (2003) Net Income : $1.600 billion for FY03 (2003) Source: via Business Wire. Updated 02/12/2004 by company. SOURCE: Business Wire (press release) http://tinyurl.com/3afnm * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn