LivaNova USA, Inc.

100 Cyberonics Boulevard

Houston, TX 77058

763.220.4110

IMPORTANT SAFETY INFORMATION

(US) CAUTION–Investigational device. Limited by Federal (or United States) law to investigational use.

(CANADA) CAUTION–Investigational Device. To be Used by Qualified Investigators Only.

 

CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS

The VITARIA®  System cannot be used on patients with a bilateral vagotomy.

The VITARIA System cannot be used on patients with a history of AV block.

Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with a VITARIA System. Diagnostic ultrasound is not included in this contraindication. Magnetic Resonance Imaging (MRI) - If MRI is required in a patient with the VITARIA System, consult the VITARIA Physician's Manual. Patients with existing ulcers (gastric, duodenal or other) may have their condition aggravated by ART. Patients with ulcers should be evaluated prior to implantation and monitored following initiation of stimulation. Potential surgery-related adverse events include hematoma, infection, pain and voice alteration (hoarseness). Potential stimulation-related adverse events include dyspepsia (indigestion), dysphagia (difficulty swallowing), dyspnea (difficulty breathing, shortness of breath), increased coughing, laryngismus (throat, larynx spasms), pain, paresthesia (prickling of the skin), pharyngitis (inflammation of the pharynx, throat), satiety (reduced appetite), sensation of stimulation, and voice alteration (hoarseness).

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