The Neurological Devices Panel (the Panel) met on Tuesday, June 15, 2004 in Gaithersburg, MD to discuss and make a recommendation to the Food and Drug Administration (FDA) on the approvability of the Cyberonics, Inc. PMA, P970003/S50 for the Vagus Nerve Stimulator (VNS) Therapy System intended for the adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode that has not had an adequate response to two or more antidepressant treatments. The Panel membership for this meeting consisted of four psychiatrists, one interventional neuroradiologist, two neurologists, a statistician, a consumer representative, and an industry representative.
The sponsor presented its information on the safety and effectiveness of the device, and FDA reviewers summarized the data in the PMA. After deliberations on the information in the submission, the Panel considered FDA’s questions.
The Panel then voted five to two to recommend that FDA approve the PMA with conditions. The recommended conditions of approval are as follows:
- Patients should have failed four or more trials of traditional treatment modalities for treatment-resistant depression (medications and electroconvulsive therapy) prior to use of the device.
- The device be implanted by surgeons with appropriate training.
- Training regarding device electronic programming be provided for primary care providers.
- Additional patient labeling for use of the device and identification card be provided.
- A patient registry to collect clinical data be established.
- The physician labeling be revised regarding the following: 12 month open label follow-up, the variable effect of treatment, patient selection, and deletion of imaging claims.
The Panel members who voted against conditional approval believed a new study was necessary to establish a reasonable assurance of safety and effectiveness of the device.
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