More than 1 billion people around the world live with high blood pressure, a serious health condition that often has no symptoms but is the leading contributor to deaths worldwide.1

Dubbed “the silent killer,” for many years the only way to treat hypertension was through diet and lifestyle changes, or by taking medication. Now, people with hypertension, or high blood pressure, have an additional treatment option — a minimally invasive procedure that uses radiofrequency to disrupt overactive nerves in the kidneys to reduce blood pressure.2

The Symplicity™ Spyral system, which was granted FDA breakthrough designation, is the product of more than a decade of rigorous clinical trials and research. More than 25,000 people worldwide have been treated with the system, also known as the Symplicity blood pressure procedure.3

“This is a revolution in the fight against high blood pressure, especially for patients whose hypertension doesn’t respond to drugs, or for people who struggle to keep up with their regimen,” said Jason Weidman, SVP and president of Coronary and Renal Denervation at Medtronic.

The procedure was even named to the Fortune 2024 "Change the World" list, which showcases companies making significant positive social or environmental impact across healthcare, technology, and other industries.

Innovation that makes a difference

The Symplicity Spyral RDN system is the product of years of clinical research, design innovation, and perseverance — an example of Medtronic learning from data to bring new treatments to patients. One of the lessons learned over the years eventually inspired the device’s name. Instead of having a single electrode with one point of energy delivery, the design evolved to a four-electrode spiral, to offer the highest chance of an effective ablation.2 Once the procedure is complete, the thin tube, or ablation catheter, is removed. And the design of Symplicity has another benefit: It’s a one-size-fits-most device that can treat virtually all patients.4 During clinical trials, 97% of patients were included, after adjusting for blood pressure screen outs, a far higher percentage than other devices and trials.5,6,7

A tremendous unmet need

High blood pressure has serious health risks and is extremely common, affecting all genders, young and old, people who are fit, and people with other health problems. About 50% of all adults in the United States have hypertension8 — and nearly 80% of them do not have their high blood pressure under control.9 If you have high blood pressure, your heart must work harder, which can raise your risk of heart attacks, strokes, heart failure,10 kidney failure,11 and a host of other conditions.

A pioneering patient’s story

One person benefitting from the procedure is Paul Griffin of Atlanta, Georgia, who used medication for decades to try to control his hypertension. The 69-year-old eventually was taking four medications a day, and his blood pressure was still not in control. After enrolling in a clinical trial, Griffin saw a profound change. “My blood pressure improved almost immediately after the procedure,” he said. “I’m seeing a reduction in my blood pressure and I’m feeling more vibrant and energetic. And I rest easier every night feeling like we finally have this under control.”†

  

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Reducing high blood pressure by 10 mmHg can significantly cut people’s risks of serious health complications, including: a 20% reduction in risk of major cardiovascular events, a 27% reduction in stroke risk, and a 28% reduction in risk of heart failure.12

In combination with medication and lifestyle changes, renal denervation opens the door to manage high blood pressure in the long term through a safe and effective procedure. It’s absolutely exciting to think about how this complementary therapy can help treat the problem of high blood pressure for many more people.”

— Dr. David Kandzari, Chief, Piedmont Heart Institute, and Chief Scientific Officer, Piedmont Healthcare in Atlanta, Georgia

Dr. David Kandzari

The Symplicity blood pressure procedure represents a milestone in treatment of hypertension, bringing hope for millions of people across the United States and helping to fill a critical gap in high blood pressure treatment.

“Patients really want other options,” Weidman told Medical Design & Outsourcing. “We’re in a great spot to help a lot of patients, and we’re going to fill a void that’s desperately needed for this global epidemic of hypertension.”

† Results may vary. Not all patients may see a drop in blood pressure. Talk to your doctor to learn more about the procedure.

  1. Hypertension fact sheet. World Health Organization. Available at https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed January 12, 2023.
  2. Coates P, Tunev S, Trudel J, Hettrick DA. Time, temperature, power, and impedance considerations for radiofrequency catheter renal denervation. Cardiovasc Revasc Med. September 2022;42:171–177.
  3. Medtronic data on file. RDN Catheter Historical Data, June 2023. Data include both Symplicity Flex and Symplicity Spyral.
  4. Medtronic Symplicity Spyral multi-electrode renal denervation catheter instructions for use.
  5. 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, shamcontrolled trial. Lancet. May 2, 2020;395(10234):1444–1451.6. Kandzari DE, et al. J Am Coll Cardiol. 2023;82:1809–1823.
  6. Kandzari D, Townsend R, Kario K, et al. Safety and efficacy of renal denervation in patients taking antihypertensive medications. J Am Coll Cardiol. November 7, 2023;82(19):1809–1823.
  7. Azizi M, et al. Lancet. 2018;391:2335-2345. Azizi M, et al. JAMA. 2023;329:651-661. Azizi M, et al. Lancet. 2021;397:2476-2386.
  8. U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020.
  9. Hypertension fact sheet. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed August 28, 2023
  10. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. June 2018;71(6):1269-1324.
  11. High blood pressure dangers: Hypertension's effects on your body. Mayo Clinic. Available at https://www.mayoclinic.org/diseases-conditions/high-blood-pressure/in-depth/high-blood-pressure/art-20045868. Accessed January 12, 2023.
  12. Ettehad D, Emdin CA, Kiran A, et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet. March 5, 2016;387(10022):957–967.

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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 a 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 707-525-0111 or Medtronic’s website at Medtronic.com