Medtronic Files for Pre-Market Approval for Epilepsy Device

epilepsyMedtronic has filed for pre-market approval with the U.S. Food and Drug Administration for an implantable device to help patients with severe, treatment-resistant epilepsy. Medtronic Deep-Brain Stimulation(DBS) Therapy is designed to treat patients with uncontrollable seizures who do not respond to medication.

The Minneapolis company’s application includes data from the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) long-term clinical trial, which is still running.  According to data released in December 2008, the majority of patients in the SANTE study showed a significant reduction in seizures. Some patients have used Medtronic DBS Therapy for over four years.

Epilepsy is often described as a lightning storm in the brain. Instead of firing normally, neurons fire over and over, causing a power surge that can disrupt normal brain function and cause seizures. The Epilepsy Foundation reports that over 3 million people in the U.S. suffer from epilepsy. About one-third of sufferers have uncontrollable seizures that don’t respond to medication.

Medtronic DBS Therapy works much like a pacemaker. The surgically implanted device delivers electrical stimulation to targeted areas of the brain. Clinicians can adjust the electrical stimulation non-surgically to fit each individual patient. The system was previously approved by the FDA for the treatment of conditions including advanced Parkinson’s disease and treatment-resistant obsessive-compulsive disorder.

Seeking Alpha believes that Medtronic is “positioned for long-term growth.” The financial analysis website reports that Medtronic’s Reclaim DBS Therapy for obsessive-compulsive disorder recently became the first DBS therapy to receive CE Mark approval in Europe. Reuters has more information on the European approval.

Medtronic isn’t the only company developing products to manage and treat epilepsy. Cyberonics of Houston markets an implantable electrical device, VNS Therapy, that has been approved to treat epilepsy since 1997. Neurovista is developing an “early warning” system to detect the physiological signals associated with an impending seizure. MedGenesis and D-Pharm have epilepsy medications in their pipelines.

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