The Food and Drug Administration Wednesday said Medtronic Inc.’s deep brain stimulation (DBS) device to treat epilepsy failed to meet the major goals of its clinical study.
Over a three month period, the company failed to demonstrate that patients using the device experienced less seizures than patients in the control group who did not receive the therapy, according to FDA documents.
“Do the data represent a clinically significant difference for a deep brain stimulation device as compared to the control?” the documents said.
A special panel of experts recruited by the FDA will question Medtronic officials on Friday.
A Medtronic spokesman did not immediately return a phone call.
Medtronic has pioneered the use of DBS therapy in the United States, a fast growing market that has attracted the interest of competitors like St. Jude Medical and Boston Scientific.
Last June, Medtronic won regulatory approval to market its Activa DBS devices to treat advanced Parkinson’s. A major study published earlier that year in the Journal of the American Medical Association concluded that Medtronic’s DBS devices worked just as well as drugs in improving the quality of life of patients suffering from Parkinson’s.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Medtronic is currently the only company selling FDA-approved, rechargable DBS devices in the country, a distinction that has helped second quarter neurostimulation sales jump 11 percent to $394 million. MIT Technology Review recently named Medtronic as one of the top 50 innovative companies in the world based on its work in DBS therapies.
The medical device industry is racing to develop DBS technologies to treat depression, obsessive compulsive disorders, and epilepsy. In 2003, Medtronic launched its 110 patient SANTE epilepsy study to test a device that uses electricity to stimulate the anterior nucleus region of the brain.
In addition to not meeting the study’s goals, the FDA also expressed some concern over safety. For example, patients reporting new or worsening anxiety, depression, and memory loss were more active in the therapy group than the control group, the agency said. One patient committed suicide while six others were reported as suicidal. The FDA also noted three patients died from Sudden Unexpected Death in Epilepsy or 7.6 deaths per 1,000 patients/years.
The FDA panel will question Medtronic over whether it believes these numbers are significant to the general population and pose significant safety concerns.
