Medtronic completes brain implants in trial of deep brain stimulation
30 July 2007
Minneapolis, USA. Medtronic, Inc. (NYSE:MDT), has
completed implants of its Intercept epilepsy control system in 110
patients as part of its clinical study of deep brain stimulation (DBS) for
the treatment of medically refractory epilepsy.
Medically refractory epilepsy is a form of the neurological condition
that does not respond to antiepileptic drugs. The trial, called SANTE
(stimulation of the anterior nucleus of the thalamus in epilepsy) is
expected to have results available during 2008.
The trial is ongoing at 17 medical centres in the United States and uses
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.
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.
The same technology is approved for
treating motor symptoms of Parkinson’s disease and essential tremor — the
two most common movement disorders.
Medtronic’s DBS therapy has been used by more than 40,000 people
worldwide, though it 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.
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.”
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.
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
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