Cyberonics has reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted the final regulatory approval to market and sell its Vagus Nerve Stimulation (VNS) Therapy System for the epilepsy indication.
The company claims that it is planing to launch its VNS Therapy System in Japan following final reimbursement authorization. The System, which is FDA-approved is being marketed for the treatments of refractory epilepsy and treatment-resistant depression. The System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve.
Dan Moore, president and chief executive officer of Cyberonics, said: “Our clinically proven VNS Therapy System, which to date has been implanted in more than 55,000 patients worldwide, will provide a unique treatment option for Japanese patients who suffer from refractory epilepsy. We are grateful for the valuable support and expertise provided by our Japanese distribution partner, Nihon Kohden in securing this approval.”
Fumio Suzuki, president, chief operating officer of Nihon Kohden, said: “We are pleased to be able to provide a new therapy option to those who suffer from refractory epilepsy in Japan. The regulatory approval in Japan for the VNS Therapy System covers all people with drug-resistant refractory epilepsy, except the cases for which surgery is recommended, but without restrictions as to age or type of epilepsy.
“Together with our EEG monitoring systems, we are now in a position to better serve medical professionals who fight this difficult-to-manage neurological disease in Japan.”