US FDA approves Medtronic deep brain stimulation therapy for refractory epilepsy
US FDA approves Medtronic deep brain stimulation therapy for refractory epilepsy
May 04, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, the US FDA approved Medtronic's deep brain stimulation therapy (DBS, a surgically implanted medical device) as an adjuvant therapy to reduce the poor treatment of three or more antiepileptic drugs. The frequency of seizures in patients with partial seizures.
This approval is particularly applicable to the stimulation of the bilateral thalamic nucleus, based on the results of the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) study. The randomized, double-blind study enrolled 110 patients who were implanted with the Medtronic DBS system and were followed for 7 years of open-label follow-up.
The trial results showed that the total median number of episodes in the DBS and placebo groups decreased by 40.4% and 14.5%, respectively, over a three-month period. In 7 years, the total number of episodes of open-label continuous treatment decreased by 75%. In addition, 18% (n=20) of patients experienced at least 6 months of no seizures after implantation to 7 years, of which 7% (n=8) had no seizures in the past two years.
The quality of life and severity of seizures in the seventh year were statistically significantly better than baseline. In addition, cognitive or depression scores did not significantly worsen during the double-blind or seventh year; at 7 years, improvement in executive function and attention was observed.
Adverse events were assessed within 2 years after implantation of the device. The most common adverse events were paresthesia (23/110), pain at the implant site (18/110), and infection at the implant site (10/110).
Medtronic plans to officially launch their DBS treatment system at the appropriate time this year. (Sina Pharmaceutical Compilation / David)
Article, image reference source: FDA Approves Deep Brain Stimulation Therapy for Refractory Epilepsy
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