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).

ABOUT HEART FAILURE

Over 25 MILLION LIVING WITH HEART FAILURE WORLDWIDE,

SEVERAL MILLION NEW DIAGNOSES EACH YEAR

1
1

Heart failure does not mean your heart has stopped working. Heart failure is a condition in which the heart cannot pump enough blood to meet your body’s needs. If you or a loved one have heart failure, you are not alone. Over 25 million people worldwide have this condition with several million new diagnoses per year.

GETTING TO KNOW YOUR HEART

The heart is a fist-sized organ that acts as a pump to send oxygen-rich blood throughout the body. In a healthy heart, each chamber contracts (squeezes) in a coordinated effort –

the upper chambers (atria) of the heart contract first, then the lower chambers (ventricles) contract. These coordinated

contractions circulate blood between the lungs and heart and to the rest of the body.

Left 

atrium

Right 

atrium

Left 

ventricle

Right 

Ventricle

THE FAILING HEART

During heart failure, the heart attempts to compensate for lost pumping power, and the heart may change its shape and result in an uncoordinated and inefficient heartbeat.

Normal heart

The walls of the heart become thin, and the chambers become enlarged, making the heart weak and inefficient

Heart failure

Heart failure
MAY WORSEN
OVER TIME

EVEN WITH CURRENTLY AVAILABLE TREATMENT

Muscle damage
and/or loss

HEART FAILURE CAUSES

Heart failure is typically a progressive condition, meaning it worsens and shortens life expectancy. There is no single cause, and sometimes the cause is unknown. Some of the most common causes of heart failure are:

  • Heart attack

  • Coronary artery disease

  • High blood pressure

  • Defective heart valves

  • Heart infection (i.e., virus)

  • Alcohol addiction

  • Illicit drug use

  • Diabetes

HEART FAILURE SYMPTOMS

 At first you might not experience any symptoms. However, over time you may experience some, or all, of the following symptoms:

  • Chronic lack of energy

  • Interrupted sleep at night due to breathing difficulties

  • Confusion and/or impaired memory

  • Increased urination at night

  • Swelling of feet and legs

  • Shortness of breath

  • Abdominal swelling or tenderness with loss of appetite

  • Cough with saliva/mucus

1.Card Fail Rev. 2017 Apr; 3(1): 7–11. doi: 10.15420/cfr.2016:25:2.

2. Blecker S, Agarwal SK, Chang PP, et al. Quality of care for heart failure patients hospitalized for any cause. J Am Col Cardiol. 2014;63(2):123-30.