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First Patient Treated With Medtronic Symplicity Spyral Renal Denervation System at Piedmont
Medtronic is pleased to announce the first patient in the U.S. has been treated with the Symplicity Spyral™ renal denervation (RDN) system, also known as the Symplicity™ blood pressure procedure, for the treatment of high blood pressure (or hypertension). The first procedure, which followed the recent United States Food and Drug Administration (FDA) approval, was performed at Piedmont Atlanta Hospital by David Kandzari, MD, chief, Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED clinical trial.
High blood pressure is the leading modifiable cause of heart attack, stroke and death.1 In fact, hypertension affects about 50% of adults in the United States2 and of these adults that are aware of their high blood pressure, about 80% don't have it under control.2 These challenges speak to the possibility that patients may benefit from an adjunctive treatment option, in addition to lifestyle changes and medications to better manage their blood pressure.
“We are thrilled to announce the U.S. launch of the Symplicity Spyral RDN system for patients with hypertension – and Dr. Kandzari couldn’t have been a better choice for our first U.S. procedure,” said Jason Weidman senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “This milestone brings potential hope to millions of Americans who might want another treatment option – other than medication and lifestyle changes - to better manage their blood pressure. We want to acknowledge everyone who has continued to back this therapy along the journey, and we’re excited to for the future of hypertension care.”
The Medtronic Symplicity blood pressure procedure is an innovative, minimally invasive procedure that delivers radiofrequency energy to nerves near the kidneys that can become overactive and contribute to high blood pressure. After sedation, the doctor inserts a single thin tube (known as a catheter), which can treat a wide range of vessel sizes, into the artery leading to the kidney. The doctor then administers energy to calm the excessive activity of the nerves connected to the kidney. The tube is removed, leaving no implant behind. The procedure is approved for use as an adjunctive treatment in patients with hypertension when lifestyle changes and medications do not adequately control blood pressure.
“It’s an exciting opportunity to begin this new chapter of hypertension treatment with the first U.S. procedure using the Symplicity Spyral RDN system,” said Dr. Kandzari. “For people with hypertension, medication and/or lifestyle changes can help reduce blood pressure, but studies have shown that many people still don’t gain control over their condition. I am inspired by the potential of this complementary therapy to help treat the issue of high blood pressure for so many patients. We look forward to the future of hypertension care with this milestone.”
Approved for commercial use in more than 70 countries around the world, the Symplicity Spyral Renal Denervation System is currently limited to investigational use in Japan, China, and Canada.
1 Bundy JD, Mills KT, Chen J, et al. Estimating the Association of the 2017 and 2014 Hypertension Guidelines With Cardiovascular Events and Deaths in US Adults: An Analysis of National Data. JAMA Cardiol. 2018 Jul 1;3(7):572-581.
2 Facts about Hypertension. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/bloodpressure/facts.htm. Accessed August 10, 2023.
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