Cyberonics Inc announced that its proprietary, implantable vagus nerve stimulation device, the NeuroCybernetic Prosthesis (NCP) System, has received CE Mark approval for the treatment of depression, from N.V. KEMA, an official Notified Body representing the EU member countries.
With this approval, the NCP System is now cleared for sale in all European Union member countries for the treatment of chronic or recurrent depression in patients that are in a treatment-resistant or treatment-intolerant major depressive episode. This includes the treatment of patients with major depressive disorder or so-called unipolar depression, as well as patients with bipolar disorder (manic depression).
CE Mark approval was granted following consideration of the results from the D-01, 60-patient depression study including the one-year long-term follow up data on the first 30 D-01 patients. The patients included in the D-01 study suffered from treatment resistant or recurrent depression or bipolar disorder.
During the acute study, over 30 per cent of the 60 study patients demonstrated a significant improvement in depressive symptoms. Results of the one year long-term follow-up on the first 30 patients show that 46 per cent of patients after one year of VNS experienced at least a 50 per cent improvement in their depression and 29 per cent were free of depressive symptoms. The one year follow-up also showed that the response to VNS was largely maintained or improved over time as 91 per cent of responders at the end of the acute study maintained their response and 18 per cent of non-responders at the end of the acute study were responders at one year.
"Cyberonics' mission in depression is to partner with psychiatrists to develop innovative long-term therapies which improve the lives of patients and their families, psychiatrists, surgeons, hospital personnel and payers touched by chronic or recurrent depression," commented Robert P. ("Skip") Cummins, president and chief executive officer of Cyberonics.
Cummins continued, "The approval by N.V. KEMA is the first regulatory authority validation of the effectiveness of vagus nerve stimulation as a long term treatment for depression and the appropriateness of our proposed depression labeling and indication for use. CE Mark approval clears the way for our European team to now begin to help improve the lives of over one million Europeans today suffering from treatment resistant or recurrent depression. We plan to focus our European depression resources on the larger markets where we have had success with VNS in epilepsy including Scandinavia, Germany, Austria, Switzerland, the United Kingdom and France."
Cummins concluded, "The depression pivotal program in the United States continues to be on or ahead of schedule. The D-02 double blind, randomized, placebo-controlled pivotal study will include up to 210 implanted patients and should be concluded in less than one year from today. Currently, 159 patients are enrolled, 118 are implanted and 60 patients have completed the D-02 acute study. In addition to our D-02 momentum, the depression investigators continue to report, present and publish encouraging long term results from the 60 patient D-01 depression study, exciting results from various mechanism of action studies and promising health economics data from the depression claims database cost study."
VNS therapy is delivered by the Cyberonics NCP System, an implantable medical device similar to a cardiac pacemaker. A stopwatch-sized generator is implanted in the left chest and a nerve stimulation electrode is attached to the vagus nerve in the neck in a one to two hour procedure typically done on an outpatient basis. Using an external programmer, the physician can set or reset the stimulation parameters of the device. The System delivers preprogrammed intermittent electrical pulses to the vagus nerve 24 hours a day.