"At Medtronic, we have a long-standing commitment to helping patients with medically refractory epilepsy through DBS, and we continue to explore other treatments and solutions along the epilepsy treatment pathway," said Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. "With the FDA approval, commercial launch, and policy updates from several health insurers, we are positioned to help more people than ever before. We are also initiating a 140 subject post-approval study where we will evaluate three-year safety and effectiveness outcomes at centers in the U.S. and Europe."
About Medtronic DBS Therapy
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for several neurological disorders. Medtronic DBS systems were the first approved for full-body MRI scans under specific conditions in the United States. Since 1997, more than 150,000 Medtronic DBS devices have been implanted worldwide.
Ad Statistics
Times Displayed: 21862
Times Visited: 433 Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money
In addition to medically refractory epilepsy, DBS therapy is currently approved in many locations around the world, including the U.S. and Europe, for the treatment of the disabling symptoms of essential tremor and recent and longer-standing Parkinson's disease. Under Humanitarian Device Exemption (HDE) approvals in the United States, the therapy can also be used to treat chronic intractable primary dystonia and severe, treatment-resistant obsessive-compulsive disorder.
The FDA-approved indication for epilepsy is as follows: Bilateral anterior thalamic nucleus stimulation using the Medtronic DBS System for Epilepsy is indicated as adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications. The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness in patients who averaged six or more seizures per month over the three most recent months (with no more than 30 days between seizures) and has not been evaluated in patients with less frequent seizures.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Back to HCB News
