By Thomas Lee
Medtronic Inc.’s (NYSE:MDT) Activa deep-brain stimulation device failed to meet the major goals of a clinical study examining its use in treating epilepsy, according to Food & Drug Administration documents.
The Fridley, Minn.-based medical devices monolith’s study of the device, which sends a trickle of electric current to the anterior nucleus region of the brain, 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 asked.
A special panel of experts recruited by the FDA will question Medtronic officials March 12.
A Medtronic spokesman did not immediately return a phone call seeking comment.
Medtronic has pioneered the use of DBS therapy in the United States, a fast-growing market that has attracted the interest of competitors including St. Jude Medical Inc. (NYSE:STJ) and Boston Scientific Corp. (NYSE:BSX).
Last June, Medtronic won regulatory approval to market its Activa DBS devices to treat advanced Parkinson’s disease. A major study published earlier in 2009 in the Journal of the American Medical Assn. concluded that Medtronic’s DBS devices worked just as well as drugs in improving the quality of life of patients suffering from Parkinson’s disease.
Medtronic is currently the only company selling FDA-cleared, rechargeable DBS devices in the country, a distinction that helped push second-quarter neurostimulation sales up 11 percent, to $394 million. And MIT Technology Review recently named the firm 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 the 110-patient Sante epilepsy study to test the Activa device, which drew criticism from the FDA for not meeting its goals.
The FDA also expressed concern over safety. For example, epileptic patients reporting new or worsening anxiety, depression and memory loss were more active in the therapy group than the control group, according to the federal watchdog agency. One patient committed suicide and six others were reported as suicidal. The FDA also noted the deaths of three patients from Sudden Unexpected Death in Epilepsy.
The FDA panel Friday will question company representatives over whether Medtronic believes the data are significant to the general population and pose significant safety concerns.
