The U. S. regulators are expressing a doubt on whether the sales of Medtronic Inc.'s deep-brain stimulation system be curbed or not, in view of its dangerous outcomes like suicide, depression and attacks.
"The product failed to meet the study's primary goal of reducing the number of seizures after three months compared with a control group", stated the FDA.
Around 60,000 cases of deep-brain stimulation have been witnessed, so far.
"In light of instances of increased, worsening, or new seizures, the panel will be asked whether they believe the device provides a reasonable assurance of safety, and to provide labeling recommendations", quoted the FDA officials in their report.
According to the data collected from Bloomberg, Medtronic's brain-stimulation device marked a sale of $1.15 billion in the 2009, contributing to the revenue by 7.8%.
Its shares were found trading at $44.63 on Wednesday.
The DBS functions by sending electronic signals to intended potions of the brain. The company is seeking a green signal from FDA for recommending the device for epilepsy patients.












