Its deep brain stimulator won Europe's OK for some kinds of epilepsy treatment.
Medtronic Inc. said Thursday that it has received European regulatory approval to use its deep brain stimulation therapy to control seizures in some epilepsy patients.
The Fridley-based medical technology giant has developed an implantable, pacemaker-like device that delivers controlled electrical pulses to the part of the brain that involve seizures.
European approval, called CE Mark, was based on a 110-patient clinical trial that was conducted at 17 hospitals in the United States, none of them in Minnesota.
While the World Health Organization estimates that 50 million people suffer from epilepsy, Medtronic's recent European approval covers a small subset of adults who suffer from "partial-onset seizures" that affect only a certain part of the brain. These patients typically cannot control their seizures solely with drugs.
Medtronic will begin introducing the device to hospitals throughout Europe by the end of the year.
All told, some 75,000 people worldwide have been treated with Medtronic's deep brain stimulation therapy. The device is available in Europe and the United States for treatment of essential tremor and advanced Parkinson's disease.
It is approved in Europe for dystonia and obsessive-compulsive disorder, although use of the device for those conditions is limited in the United States.
U.S. timeline unclear
It's unclear when the therapy will be available in the United States for partial-onset seizures in epilepsy patients who don't respond to other treatments.
The Food and Drug Administration is reviewing Medtronic's application to broaden use of the device.
Medtronic spokeswoman Cindy Resman said the company "cannot predict the FDA timeline."
"We know that the FDA has requested additional data, which will require further clinical study and we will continue to work with the FDA to determine the requirements for approval," Resman said. "This will take time."
Janet Moore • 612-673-7752