Medtronic wins FDA PMA for DBS epilepsy treatment

Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Deep Brain Stimulation therapy, indicated as an adjunctive treatment for reducing the frequency of partial-onset seizures. The DBS treatment is cleared for patients 18 years or older who are refractory or drug resistant to three or more antiepileptic medications, the Fridley, Minn.-based company said. Medtronic’s DBS therapy functions through the delivery of controlled electrical pulses to the anterior nucleus of the thalamus which is part of a network involved in seizures, the company said. Approval came based on seven years of data from the company’s Sante trial, which examined the use of the DBS system in 110 patients with medically refractory epilepsy with partial-onset seizures. “Many patients in the United States with severe epilepsy are not able to control their seizures with currently-available drugs and are not candidates for potentially curative surgery. Epilepsy that is refractory to AED treatment is an unsolved problem, and DBS therapy will now serve as an important new treatment option, including for people with poorly localized or multiple regions of seizure origin,” Sante trial lead principal investigator Dr. Robert Fisher of the Stanford Epilepsy Center said in a prepared statement. Results from the Sante trial indicated the median total seizure frequency reduction from the baseline was 40.4% at three months, versus 14.5% in a placebo group, and 75% at seven years. A...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Neurological Neuromodulation/Neurostimulation Pre-Market Approval (PMA) Regulatory/Compliance Medtronic Source Type: news