Medtronic, Inc. (NYSE: MDT), today announced the completion of implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the treatment of medically refractory epilepsy, a form of the neurological condition that does not respond to antiepileptic drugs. With 110 patients now implanted with the Intercept™ Epilepsy Control System, results of the study – the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) Trial – are expected to be available during 2008.Ongoing at 17 medical centers in the United States, the SANTE Trial is using existing Medtronic DBS technology to determine whether bilateral stimulation of the anterior nucleus of the thalamus – the brain’s central message and relay station – can safely and effectively reduce seizure frequency in people with epilepsy. The same technology is approved for treating motor symptoms of Parkinson’s disease and essential tremor – the two most common movement disorders. It has been used by more than 40,000 people worldwide, however, Medtronic’s DBS therapy has not yet been approved for use in medically refractory epilepsy. Unlike other treatments that involve brain surgery, DBS therapy is non-destructive, adjustable and reversible.
All implanted patients in the SANTE Trial will be monitored for 13 months following implant, with long-term follow-up continuing until the device is approved for treating epilepsy or the study is stopped. Trial participants are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. (Individuals with partial-onset epilepsy have seizures that originate in a localized area of the brain.) To qualify for enrollment, study patients were required to have had an average of six or more seizures per month. They continue to receive their epilepsy medications while participating in the trial.
“Despite best medical management, a significant proportion of people with epilepsy continue to experience seizures that wreak havoc on their lives,” explained the trial’s principal investigator, Dr. Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University in Palo Alto, Calif. “For this underserved patient population, deep brain stimulation may represent a promising new treatment option.”
According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. Despite trying a range of treatment options, about one-third of people with epilepsy continue to experience debilitating, recurring seizures – brief periods of abnormal electrical activity in the brain. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.
“The SANTE Trial is one of several major studies that Medtronic is sponsoring or supporting to establish compelling clinical evidence for approved and investigational applications of our neuromodulation technologies, which include implantable neurostimulation systems and site-specific drug-delivery systems,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “With this latest milestone complete, we are one step closer to understanding the effectiveness of DBS therapy for patients with medically refractory epilepsy.”
Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.
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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 the world.
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