VNS THERAPY FOR DEPRESSION INDICATIONS FOR USE (US)
The VNS Therapy System is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

CONTRAINDICATIONS
The VNS Therapy System cannot be used in patients after a bilateral or left cervical vagotomy. Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with the VNS Therapy System.

WARNINGS
All potential risks and adverse events are discussed in the VNS Therapy System physician’s manuals. VNS Therapy may not be a cure for depression. Individual results will likely vary. Beneficial results might not become evident for months. Most patients will continue to require antidepressant medications and/or electroconvulsive therapy (ECT) in addition to VNS Therapy. Patients being treated with adjunctive VNS Therapy should be observed closely for clinical worsening and suicidality, especially at the time of VNS Therapy stimulation parameter changes or drug dose changes. Patients who have pre-existing swallowing, cardiac, or respiratory difficulties (including, but not limited to, obstructive sleep apnea and chronic pulmonary disease) should discuss with their physicians whether VNS Therapy is appropriate for them, since there is the possibility that stimulation might worsen their condition. Patients with the VNS Therapy System implanted should have MRI procedures performed only as described in the MRI Chapter of the Physician Manual.

ADVERSE EVENTS
The most commonly reported side effects from stimulation include hoarseness (voice alteration), paresthesia (prickling feeling in the skin), dyspnea (shortness of breath), sore throat and increased coughing. Other adverse events reported during clinical studies as statistically significant are ataxia (loss of the ability to coordinate muscular movement); dyspepsia (indigestion); hypesthesia (impaired sense of touch); insomnia (inability to sleep); laryngismus (throat, larynx spasms); nausea; pain; pharyngitis (inflammation of the pharynx, throat); and vomiting. These typically occur only during stimulation, and are well tolerated and noticed less as time goes on. The most commonly reported side effect from the implant procedure is infection.

*THE INFORMATION CONTAINED IN THIS SUMMARY REPRESENTS PARTIAL EXCERPTS OF IMPORTANT PRESCRIBING INFORMATION TAKEN FROM THE PRODUCT LABELING. THE INFORMATION IS NOT INTENDED TO SERVE AS A SUBSTITUTE FOR A COMPLETE AND THOROUGH UNDERSTANDING OF THE VNS THERAPY SYSTEM NOR DOES THIS INFORMATION REPRESENT FULL DISCLOSURE OF ALL PERTINENT INFORMATION CONCERNING THE USE OF THIS PRODUCT. PATIENTS SHOULD DISCUSS THE RISKS AND BENEFITS OF VNS THERAPY WITH THEIR HEALTHCARE PROVIDER. PRESCRIPTION ONLY - DEVICE RESTRICTED TO USE BY OR ON THE ORDER OF A PHYSICIAN.
LivaNova USA, Inc.
LivaNova Belgium