Important Safety Information

VNS THERAPY EUROPEAN INDICATION FOR USE

VNS Therapy is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications. The Model 106 AspireSR® (Seizure Response) features the Automatic Stimulation Mode, which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia.

CONTRAINDICATIONS:

The VNS Therapy system cannot be used in patients after a bilateral or left cervical vagotomy. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with the VNS Therapy system. Diagnostic ultrasound is not included in this contraindication. Cardiac arrhythmia (Model 106 only)—The AutoStim Mode feature should not be used in patients with clinically meaningful arrhythmias or who are using treatments that interfere with normal intrinsic heart rate responses.

WARNINGS:

Physicians should inform patients about all potential risks and adverse events discussed in the VNS Therapy Physician Manuals, including information that VNS Therapy may not be a cure for epilepsy. Since seizures may occur unexpectedly, patients should consult with a physician before engaging in unsupervised activities, such as driving, swimming, and bathing, or in strenuous sports that could harm them or others. A malfunction of the VNS Therapy system could cause painful or direct current stimulation, which could result in nerve damage. Removal or replacement of the VNS Therapy system requires an additional surgical procedure. 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. Postoperative bradycardia can occur among patients with certain underlying cardiac arrhythmias. MRI can be safely performed; however, special equipment and procedures must be used.

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. The most commonly reported side effect from the implant procedure is infection.

*The information contained here represents partial excerpts of important prescribing information from the product labeling. Patients should discuss the risks and benefits of VNS Therapy with their healthcare provider. Visit www.VNSTherapy.com for more information.

OUSADBS15-11-1000-EEA

 

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