Epilepsy patients who were implanted with a Medtronic Inc. brain-stimulation device had fewer seizure episodes over time, according to a company-sponsored study released Sunday.
The "deep-brain stimulation" system, which is targeted at patients who have repeatedly failed drug treatments, could reach the U.S. market in mid-2010. That would put Fridley-based Medtronic into competition with smaller Cyberonics Inc. of Houston.
Medtronic submitted an application to the Food and Drug Administration in June seeking approval to market its system for epilepsy backed by data released a year ago. The company is still awaiting an FDA answer, and longer-term data from the same study, released Sunday at the American Epilepsy Society's annual meeting in Boston, could bolster the case with regulators and doctors.
A short-term benefit "would not be so useful for a procedure that involved surgery and putting wires into the brain," said Robert Fisher, director of the Stanford Epilepsy Center in California and lead investigator on the "Sante" study. Fisher does not have a financial relationship with Medtronic.
The FDA recently delayed a planned November panel review for the company's system, and that review likely won't happen until early next year, William Hawkins, Medtronic's chief executive, said during a recent earnings call. Medtronic still sees potential to reach the market midyear, however.
The study included 110 patients who had epilepsy for a long time and weren't helped by at least three drugs. They were all implanted with a pacemaker-like device in the chest that sends pulses to the brain by wires, but only half received power for the first three months.
Positive results at 2, 3 years
Patients receiving therapy showed benefits in terms of fewer seizures compared with patients who had devices switched off. Devices were turned on for all patients after this initial period, and longer-term data showed a median 41 percent seizure reduction at one year, 56 percent at two years and 68 percent at three years, Medtronic said.
At the time of data analysis, 102 patients had completed two years of therapy and 57 had competed three years, Medtronic said. All patients continued to be managed with drugs.
This therapy carries potential for complications such as infections around the power generator. Most of these complications happened early, and "we haven't seen a signal of long-term side effects that have emerged in years two and three," Fisher said.
For Medtronic, epilepsy represents potential expansion for a neuromodulation business that is helping offset slowed growth in bigger cardiology markets. The neuromodulation business, where treating Parkinson's disease is a key market, posted sales of $1.43 billion in Medtronic's last fiscal year, representing about 10 percent of total sales.
