An FDA advisory panel has voted 7 to 5 in favor of approval of Medtronic’s deep brain stimulation (DBS) device, probably the Soletra, as a treatment option for medically refractory epilepsy in certain patients. The device, already approved for Parkinson’s, was only days earlier reported to have failed an important study goal. Now it is seeing new life, and potential approval, due to a kink in the latest study.
Jennifer Corbett Dooren at the Wall Street Journal explains:
A study of the device was conducted in 110 patients, but it failed to meet a study goal that looked at a reduction in the seizure rate over a three-month period.
However, the FDA said that when looking at just the third month of treatment, patients being treated with the deep-brain-stimulation device had a greater reduction in seizures compared with patients whose device was not activated.
The missed study goal was influenced by one patient who developed a different type of seizure after the device was turned on, both the FDA and Medtronic said. When the device’s power was lowered, the seizures stopped.
Medtronic asked the FDA and the panel to consider the data without the one patient, which would result in the study meeting the three-month goal, or to consider the last month of the three-month period. But the panel was divided on whether the patient should be removed from the analysis of the study.
Wall Street Journal from March 10: Medtronic Brain Stimulator Missed Study Goal
Wall Street Journal from March 12: FDA Panel Backs Device For Epilepsy
Medtronic press release: FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy …
Flashback: Medtronic’s Deep Brain Stimulation Devices Approved for Parkinson’s and Essential Tremor
