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Important Safety Information

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.

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Symplicity™ Blood Pressure Procedure

  

SYMPLICITY™ BLOOD PRESSURE PROCEDURE

Take control of your high blood pressure.

The Symplicity™ procedure works with your current treatments to help you take control when other options haven’t been enough.1,2 Take a short survey to see if it may be right for you.

Take the survey
Alert Important Safety Information

  

  

     

     

Some insurance companies, including Medicare, now cover the Symplicity™ blood pressure procedure.3

Talk with your doctor to see if you‘re eligible.

Find out more

     

     

Think beyond the typical treatments for high blood pressure.

Interested in lowering your blood pressure?1,2 The Medtronic Symplicity™ blood pressure procedure offers an innovative solution that goes beyond lifestyle changes and medications.1,2

The Symplicity™ procedure is a minimally invasive treatment designed to complement your existing efforts to manage high blood pressure.4 It works alongside the lifestyle changes and medications you may already be using to help control your blood pressure more effectively.1,2

Not every person will experience the same results. Talk to your doctor to see if the Symplicity™ blood pressure procedure is right for you. Your doctor should discuss all potential benefits and risks with you.

Find a Symplicity™ specialist
View an illustration of a heart in the middle encircled by a banana, broccoli, a bicycle, and a prescription pill bottle.

Understand your high blood pressure.

High blood pressure is very common around the world.5 It often has no symptoms, so it goes untreated.5 Not having your blood pressure under control raises the risk of heart attack, stroke, and heart and kidney failure.6,7

Decorative element

~44%

of adults with high blood pressure are unaware they have it.5

Decorative element

~75%

of adults with high blood pressure do not have it under control.5

Decorative element

> 1.4 billion

adults are affected worldwide.5

Learn about high blood pressure
View this illustration of blood pressure reading on a mobile phone.

Beyond a doubt

The Symplicity™ blood pressure procedure is a minimally invasive procedure that is proven to be safe and effective.1,2 Results may vary.

See how it works

Live beyond the risks of high blood pressure.

Find out how the Symplicity™ procedure has affected the lives of real-world patients.

Explore patient stories

 

“This procedure brought me
my life back.”

– Lisa, patient with high blood pressure who received the Symplicity™ blood pressure procedure.

Not every person will experience the same results. The Symplicity™ blood pressure procedure does have known risks. These risks should be considered in relation to the potential benefits of the procedure.

Get more answers now.

Discover and download FAQ and other tools.

Find more resources

     

1. Kandzari DE, Townsend RR, Kario K, et al. Safety and efficacy of renal denervation in patients taking antihypertensive medications. J Am Coll Cardiol. 2023;82(19):1809–1823. doi:10.1016/j.jacc.2023.08.045.

2. Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020;395(10234):1444–1451. doi:10.1016/S0140-6736(20)30554-7.

3. Centers for Medicare & Medicaid Services. Renal denervation for uncontrolled hypertension: Final decision memo. Updated October 28, 2025. Accessed October 28, 2025.

4. Medtronic Symplicity Spyral™ multi-electrode renal denervation catheter instructions for use. Medtronic; 2023.

5. World Health Organization. Hypertension fact sheet. Published March 16, 2023. Updated September 25, 2025. Accessed October 22, 2025.

6. Jones DW, Ferdinand KC, Taler SJ, et al. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. J Am Coll Cardiol. 2025;86(18):1567–1678. doi:10.1016/j.jacc.2025.05.007.

7. Mayo Clinic. High blood pressure dangers: Hypertension’s effects on your body. Published November 28, 2023. Accessed October 22, 2025.

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Customer Care Team

Hours: 8:00 a.m. - 8:00 p.m. EST 

 

Phone: 763-514-4000

Toll-free: 800-633-8766

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