Important safety information

The Symplicity™ blood pressure procedure (BPP) is a minimally invasive procedure approved to help lower high blood pressure. The procedure is approved as a complement to treatments you may already be trying, such as lifestyle modifications and high blood pressure medications that might not be adequately controlling your blood pressure.

Receiving the Symplicity BPP should be based on a joint decision between you and your doctor. Consider the benefits and risks of the device and procedure. Please talk to your doctor to decide whether or not the Symplicity BPP is right for you.

If you have a pacemaker or an ICD, your doctor will follow up with steps to take ahead of the procedure if you decide it is right for you.

At the time of your procedure, your doctor may detect certain anatomical conditions (e.g., your blood vessels are too big or too small) that do not allow the blood pressure procedure to continue.

You should not receive the procedure if you cannot tolerate medications that are required for the procedure, like atropine, nitroglycerin, systemic blood thinners, or certain pain medications. These medications are to help you in case your heart rate drops too low, you experience pain, or your blood vessels tighten during the procedure. You should not receive the procedure if you are pregnant.

The Symplicity BPP has not been studied in patients:

• Who are breastfeeding
• Who are under 18 years old
• Who have isolated systolic hypertension (only the “top number” of your blood pressure is high)
• Who have secondary causes of high blood pressure
• Who have had a renal stent placed less than 3 months prior to the procedure
• Who had a prior minimally invasive treatment in their renal arteries (stenting, angioplasty, or prior renal denervation)

Potential risks of the Symplicity BPP (note that you may experience other problems that have not been previously observed with this procedure):

• Allergic reaction to the imaging solution
• Damage to your arteries
• Future narrowing of your arteries
• Arterio-enteric fistula (an abnormal connection between your aorta and your gastrointestinal tract)
• AV fistula (an irregular connection between an artery and a vein)
• Bleeding or blood clots
• Bruising where the device enters your body (mild or severe)
• Cardiac arrest or heart attack 
• Death
• Deep vein thrombosis 
• Swelling
• Slow heart rate
• Infection
• Low or high blood pressure 
• Damage to your kidneys that may cause one or both to stop working
• Nausea or vomiting
• Peripheral ischemia (lack of blood supply to your limbs)
• Pulmonary embolism (a sudden block in your arteries that send blood to your lungs)
• Pseudoaneurysm (blood collecting on the outside of a vessel wall causing a balloon-like widening)
• Pain or discomfort
• Skin burns from the failure of the equipment during the procedure
• Exposure to radiation
• Stroke

For further information, please call and/or consult Medtronic at 800-633-8766 or the Medtronic website at medtronic.com.