The American College of Cardiology (ACC) and American Heart Association (AHA) have updated their hypertension guidelines to include renal denervation (RDN) as a treatment option for certain patients with resistant or uncontrolled high blood pressure.
The 2025 guidelines, published in the Journal of the American College of Cardiology, Circulation and Hypertension, give RDN a Class IIb recommendation. The update recognizes RDN as an adjunct to lifestyle changes and medications, following earlier support from European medical societies.
Two devices are currently FDA-approved for the procedure: Medtronic’s Symplicity Spyral renal denervation system and ReCor Medical’s Paradise ultrasound renal denervation system, the first RDN device to receive FDA approval. The Symplicity Spyral system uses radiofrequency energy to disrupt overactive nerves in the renal arteries, while the Paradise system delivers 360-degree ultrasound energy in short bursts, with a cooling mechanism to protect the artery wall.
The guidelines recommend RDN for adults whose blood pressure remains above target despite medication, including those with systolic readings of 140 mm Hg or higher and diastolic readings of 90 mm Hg or higher. RDN is not recommended for patients who are pregnant or have significant renal artery narrowing.
Medtronic noted that the ACC/AHA guidelines validate RDN as an additional option for patients who do not sufficiently respond to lifestyle modifications and pharmaceutical treatments, citing evidence from its SPYRAL HTN clinical program showing sustained blood pressure reductions for up to three years in randomized and real-world studies.
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Recor said the inclusion of RDN in the guidelines reflects an objective review of randomized, sham-controlled trials across diverse populations and affirms the therapy’s role in hypertension management.
“As leading voices in cardiovascular health practices, the AHA and ACC strengthen support for renal denervation as a treatment option for high blood pressure,” Recor President and CEO Lara Barghout said. “We are pleased to see that the strength of our RADIANCE Global Program formed the basis for the positive inclusion in the guidelines, which not only reinforce the credibility of this therapy—they directly align with the compelling clinical evidence behind the Paradise Ultrasound Renal Denervation (uRDN) System, which has consistently demonstrated safe, effective blood pressure reduction.”
Dr. Shon Chakrabarti, Recor’s chief medical officer, also said the guidelines are an important step toward integrating RDN into treatment pathways for patients with stage 2 hypertension who cannot tolerate additional antihypertensive medications.
Hypertension affects about 1.28 billion adults worldwide and is the leading modifiable cause of heart attack, stroke and death. Nearly 80% of people with hypertension do not have their blood pressure under control, according to the World Health Organization.
“These updated hypertension guidelines are pivotal for physicians, as they validate RDN as an additional option for managing hypertension in patients who do not sufficiently respond to lifestyle modifications and pharmaceutical treatments,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. “To date, we are seeing great interest from healthcare systems across the United States that are looking to offer the Symplicity blood pressure procedure. The updated renal denervation guidelines will enable greater patient access to this potentially life-changing intervention – not only in the United States, but globally as well.”
[More on RDN: How Recor Medical won the renal denervation race for FDA approval]
