Ultrasound renal denervation: A high-value treatment option for patients with uncontrolled hypertension
Nearly 120 million adults in the United States have hypertension, and just 1 in 4 of them have it under control.[1] Treatments remain limited outside of lifestyle changes and hypertensive medications that are not always effective.
Renal denervation (RDN) represents a new treatment option for many of these patients. RDN is a minimally invasive therapy that targets and ablates overactive renal nerves to modify the signals between the brain and the kidney. Though not a cure for hypertension, RDN is associated with lasting blood pressure reductions that may significantly decrease a patient’s risk of experiencing a heart attack or stroke. And ever since the first RDN systems gained U.S. Food and Drug Administration (FDA) approval in 2023, this technology has brought a new sense of hope to patients throughout the United States.
Cardiologist embraces renal denervation
Matheen A. Khuddus, MD, an interventional cardiologist and the director of cardiovascular research at The Cardiac & Vascular Institute in Gainesville, Florida, thinks many physicians still fall short when it comes to diagnosing and managing hypertension. In fact, he says even he was guilty of this early in his career, citing the therapeutic inertia commonly seen due to the many challenges associated with treating hypertension.
Khuddus credits getting his certification as a hypertension specialist with increasing his focus on this high-risk condition. He is now a staunch advocate for individuals with uncontrolled hypertension, doing everything he can to take care of these patients.
“We know hypertension is a huge problem,” Khuddus says. “It’s one of the primary reasons patients go to the doctor and one of the primary reasons doctors write prescriptions for their patients. Despite all of that, hypertension is still not optimally managed or controlled in the vast majority of patients further highlighting the need for new therapeutic options for patients.
Through his clinical research role at The Cardiac & Vascular Institute, Khuddus participated in the RADIANCE trials to help investigate the safety and effectiveness of Recor Medical’s Paradise Ultrasound RDN (uRDN) system. The experience, he says, opened his eyes to uRDN’s potential to dramatically improve the cardiovascular health of patients who have been unable to control their hypertension with medication alone. Once the Paradise uRDN system gained FDA approval, Khuddus and his team were early adopters of the technology in their own cath labs.
“As an interventional cardiologist, I welcome as many tools as possible in the toolbox to help take care of my patients,” he says. “Patients are responding really well to uRDN, even better than we expected based on the clinical trial data. I think a lot of physicians are skeptical at first and think it may not add much value, but these patients are seeing real-world reductions in blood pressure that are really impressive. In my experience, patients who respond to treatment with uRDN have seen a systolic blood pressure reduction averaging around 15 mm Hg.”
“Every minute in the cath lab counts, and I can perform ultrasound renal denervation quickly and efficiently. Efficiency in the cath lab is always valued, especially when it comes to a high-volume procedure.”
Matheen A. Khuddus, MD,
Interventional Cardiologist and Director of Cardiovascular Research at The Cardiac & Vascular Institute
Khuddus notes that blood pressure medications eventually wear off, causing the patient’s blood pressure to go back up unless they take another dose. With uRDN, however, the impact is not only impactful but also results in an “always on” effect that is continuous.
“I tell patients it is like a pill you take once that keeps working year after year,” he says. “Long-term follow-up from the ACHIEVE Study shows that the blood pressure-lowering effect of the Paradise uRDN system is sustained for up to eight years, with no evidence of diminishing effect over time in the studied cohort.[2]”
Helping patients live their best lives
Khuddus recalls the first patient he treated with the Paradise uRDN system once it was commercially available.
“His blood pressure was just very, very difficult to control,” Khuddus says. “He was on a lot of medications, but his blood pressure was still markedly elevated—and the side effects resulted in him being in and out of the hospital. After we performed uRDN, his blood pressure dropped and his medication burden went down considerably. He experienced a huge improvement in his quality of life, all from that one procedure.”
While treating hypertensive patients always starts with lifestyle changes and medications, Khuddus says it was a relief to finally be able to help people for whom those are not enough.
“I’m still a big proponent of optimizing medical therapy, but some patients are unable to take medications for one reason or the other,” he says. “Maybe the side effects are too bad, the regimen is too complex or the financial burden is too much to keep up with month after month. Those are real obstacles that have to be dealt with.”
The many benefits of ultrasound energy
What sets the Paradise uRDN technology apart from other RDN systems is its use of ultrasound energy for ablation. The system delivers 360° of ultrasound energy to the main renal arteries in seven-second bursts. This penetrates the tissue at a depth of up to 6 mm, ablating overactive sympathetic nerves all around the renal artery to disconnect or modify the overactive signal between the brain and kidney, without the need to ablate in the distal branches. Each patient receives a total of two or three seven-second bursts of ultrasound along both sides of the artery.*
Khuddus sees uRDN as a simple, fast and straightforward procedure that allows clinicians to take care of patients in a timely manner. He points as well to robust clinical data that supports the use of uRDN.
“Every minute in the cath lab counts, and I can perform uRDN quickly and efficiently,” he says. “Efficiency in the cath lab is always valued, but especially when it comes to high-volume procedures. Eventually, the number of these procedures being performed will increase substantially and uRDN will allow for patients to be treated quickly and with excellent outcomes.”
And it’s not just about the more predictable procedure time being better for a health system’s bottom line—spending less time ablating the patient’s renal nerves is associated with a wide variety of benefits.
“One thing I really appreciate about the speed is the minimal amount of contrast and fluoroscopy that is required,” Khuddus explains. “This is really important when you think about safety and specifically patients who often have some degree of underlying renal dysfunction. The shorter duration of treatment is also less of an opportunity for that patient to experience any amount of pain even with the use of heavy sedation.”
Yet another thing Khuddus values about uRDN is the small learning curve due to the familiarity with using a balloon based catheter. Interventional cardiologists with a variety of skill levels are therefore able to perform safe, effective uRDN procedures with minimal training.**
Reimbursement on the upswing
Reimbursement for RDN continues to evolve. Currently, RDN is supported by Category III CPT codes, along with a New Technology Add-On Payment (NTAP) for inpatient cases and a Transitional Pass-Through (TPT) payment for outpatient cases. But that’s not all; major developments are in the works that will take reimbursement for RDN to another level.
In January, the U.S. Centers for Medicare and Medicaid Services (CMS) announced it was considering a national coverage determination (NCD) for RDN and requested feedback. The greater cardiology community responded to the news with enthusiasm, with the American College of Cardiology, Society for Cardiovascular Angiography and Interventions and Society for Vascular Medicine signing a letter to CMS in support of improved explicit coverage. The groups described RDN as a “valuable alternative for managing uncontrolled and resistant hypertension when traditional treatments are insufficient.”[3]
Reimbursement for Ultrasound Renal Denervation: Key Things to Know
- CMS approved a new technology add-on payment for inpatient cases, which is now active. The additional reimbursement is up to $14,950. This payment is temporary, lasting up to three years. The unique ICD-10-PCS billing code is X051329.
- CMS approved a transitional pass-through payment for outpatient cases, which is now active. This payment is temporary, lasting up to three years. The unique HCPCS Code for uRDN is C1736.
- CMS has proposed a national coverage determination for renal denervation. A final decision is expected by October.
- Renal denervation is currently associated with a CPT Category III code.
In July, CMS released the proposed NCD coverage criteria that would establish eligibility for all Medicare patients, including those enrolled in Medicare Advantage.[4] A final policy determination is expected in October.
“From a reimbursement standpoint, RDN has made significant progress since FDA approval,” Khuddus says. “And it’s only going to get better.”
Renal denervation included in new society guidelines
Some more good news came in August when the ACC and American Heart Association (AHA) released updated guidelines for the diagnosis, management and treatment of patients with high blood pressure that include multiple recommendations for RDN.[5]
RDN’s inclusion in the updated guidelines reinforces the growing role of this technology in day-to-day treatment of hypertensive patients. It also helps demonstrate just how quickly RDN has become a cornerstone of modern treatment strategies. When the last ACC/AHA hypertension guidelines were released back in 2017, Recor Medical was still developing the Paradise uRDN system. Now, its use is being promoted as a safe, effective treatment strategy to bring relief to a wide variety of patients.
‘Never too late’ to establish a hypertension program
RDN’s emergence represents one of the most significant breakthroughs to date for patients with uncontrolled hypertension. And to get the most out of this new technology, Khuddus says he believes hospitals and cardiology practices need to start establishing hypertension programs geared for these patients.
“If you don’t have a hypertension program yet, it’s never too late,” he says. “It’s the right time. We need more clinics, more home blood pressure monitoring, more remote patient monitoring, more ambulatory blood pressure monitoring and established hypertension care pathways. Those are all really important parts of a successful program and are crucial to help you determine which patients will benefit the most from RDN.”
* Treatment site may vary with anatomy. Please refer to Paradise Catheter IFU for treatment strategy.
** Most common risks and individual results may vary. Approximately two-thirds of patients experienced a drop > 5 mm hg with uRDN in clinical trials.
References:
1. Hypertension Cascade: Hypertension Prevalence, Treatment and Control Estimates Among US Adults Aged 18 Years and Older Applying the Criteria From the American College of Cardiology and American Heart Association’s 2017 Hypertension Guideline—NHANES 2017–2020. Centers for Disease Control and Prevention (CDC). May 12, 2023. Accessed Aug. 7, 2025.
2. V. Zeijen, ACHIEVE Study update. TCT 2023. N=27
3. Biga, Hermiller, Ratchford. RE: CAG-00470N Renal Denervation for Uncontrolled Hypertension. https://scai.org/sites/default/files/2025-02/RDN_NCA_2.12.pdf. Accessed Aug. 7, 2025.
4. Renal Denervation for Uncontrolled Hypertension. July 10, 2025. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx. Accessed Aug. 7, 2025.
5. Daniel W. Jones, MD, 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. JACC. Aug. 14, 2025.
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© 2025 Recor Medical, Inc. All rights reserved. RECOR MEDICAL, PARADISE, HYDROCOOLING, SONOWAVE 360, RADIANCE, the GPS logo, and the Swirl logo are registered trademarks in the EU and other countries, RECOR and the RADIANCE logo are also trademarks of Recor Medical, Inc. The Paradise System is FDA approved and indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. See ISI below. The Paradise System is FDA approved in the United States, is CE marked and approved for sale in markets where the CE mark is accepted per approved indications for use, and received manufacturing and marketing approval in Japan.
This article is sponsored by Recor Medical. Dr. Khuddus is a paid consultant of Recor Medical, Inc., and has been compensated for his time and expertise in participating in this content. The views expressed in the article are his own and based on his own personal experience with the Paradise System. Results may vary.
*Important Safety Information*
Rx Only. Brief Summary - Prior to use, please reference the Instructions for Use
Indications for Use
The Paradise Ultrasound Renal Denervation System (Paradise System) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
Contraindications
The Paradise Catheter is contraindicated in any of the following:
- Renal arteries diameter <3 mm and >8mm
- Renal artery Fibromuscular disease (FMD)
- Stented renal artery
- Renal artery aneurysm
- Renal artery diameter stenosis >30%
- Pregnancy
- Presence of abnormal kidney (or secreting adrenal) tumors
- Iliac/femoral artery stenosis precluding insertion of the catheter
Warnings
- Failure to use the recommended balloon size may result in renal artery stenosis, dissection, perforation, aneurysm, significant vasospasm requiring intervention, ablation of unintended tissues or structures, and/or no ablation of target tissue achieved.
- Energy emission in an unintended location may result in unintended tissue damage.
- Do not move the Paradise Catheter during sonication.
- Do not sonicate in renal artery at locations with visible plaque.
- Do not deliver sonications in an overlapping arterial target zone.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.