Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European Union for its deep-brain stimulation device for epilepsy.
The approval clears Fridley, Minn.-based Medtronic to begin marketing the device in Europe as an adjunct treatment for partial-onset epileptic seizures in adults who don’t respond to treatment with drugs. The device delivers controlled electrical pulses to the thalamus to disrupt the electrical circuit thought to cause epileptic seizures.
Medtronic said the approval was based on its Santé clinical trial of its Activa device. The results published in the journal Epilepsia, showed that about 40 percent of patients treated with the device showed a decline in seizures after three months. After two years, there was a 56 percent median percent reduction in seizure frequency and 54 percent of patients experienced less than half the number of seizures. Fourteen patients had no seizures for at least six months during the trial and the device seemed to reduce the severity of seizures in some patients.
“Complex partial and ‘most severe’ seizures were significantly reduced by stimulation,” according to the study, which also noted that participants who received DBS “were more likely to report depression or memory problems" as adverse events.
Medtronic is seeking supplemental pre-market approval from the Food & Drug Administration, but the technology’s reception on this side of the pond has been less warm. An FDA panel narrowly recommended approval of the Activa device, citing the agency’s concerns about clinical evidence that the device works no better than conventional therapies and referencing the reports of depression and memory problems. The FDA review panel’s green light came with conditions: Medtronic must perform a post-approval study to meet long-term follow-up and labeling requirements.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.