Can brainpacemaker control seizures?
Medtronic, Inc. (NYSE:MDT) today announced that the U.S. clinical trial for its Intercept(TM) Epilepsy Control System has met an early milestone. Based on the intended interim review of blinded safety and efficacy data by an independent data safety and monitoring board, enrollment in the trial will continue, and the study of this innovative therapy will progress as planned.
This decision allows Medtronic to advance its focus on the unmet needs of individuals with epilepsy. Specifically, the Intercept trial will further explore the application of Medtronic's already proven neurostimulation technology to reduce seizure frequency and severity in people with difficult-to-treat epilepsy.
"We are encouraged by the board's decision, and are very pleased that the trial will move forward as this pioneering therapy provides hope for so many people who suffer through life with uncontrolled seizures," said Todd Langevin, vice president and general manager, global movement disorders, Medtronic Neurological.
Currently, 15 sites in the U.S. are participating in the pivotal trial, and more than half of all patients needed to complete the trial are enrolled. If the Intercept development plan continues to progress on target, the device could be available for patients as early as 2008.
About Epilepsy
According to the Epilepsy Foundation, epilepsy is a neurological condition that affects 2.7 million Americans and 50 million people worldwide. Despite trying a range of treatment options, about one-third of these people continue to experience debilitating, recurring seizures - or brief periods of abnormal electrical activity in the brain. These seizures can cause a change in sensation, awareness or behavior. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social activities.
About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results.
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