Into the Dalton Family | Melody Medical: Opening a New Chapter in RDN Therapy, Netrod® — China's Original Innovation — Takes the Global Stage

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Hypertension is one of the world's most common and prevalent diseases, severely impacting patients' health and quality of life. Nearly 1.28 billion adults globally suffer from hypertension, yet the awareness rate stands at only 54%. Over 700 million hypertensive patients remain untreated, and just 21% of adults with hypertension have their blood pressure under control. The prevention and treatment of hypertension carries profound significance for patients, families, and society at large.

Beyond lifestyle modifications and pharmacological treatment, non-pharmacological hypertension therapy has become a major research focus in recent years. Among these approaches, RDN (Renal Denervation, renal artery sympathetic nerve radiofrequency ablation) represents the most important advance in minimally invasive interventional treatment for hypertension. On May 17, 2023 — the 19th World Hypertension Day — at EuroPCR 2023, a premier global cardiovascular conference, the clinical trial results for the safety and efficacy of Shanghai Magic Leap Medical Technology's Netrod® mesh multi-electrode renal artery radiofrequency ablation system in treating uncontrolled essential hypertension were officially presented during the Late Breaking Clinical Data session. The study was led by Professor Yujie Zhou's team from Beijing Anzhen Hospital, Capital Medical University.

"A decade of refinement, for the hard truth of blood pressure reduction. Our clinical research spanned seven years across 25 centers, with the collective efforts of numerous experts. The results presented at EuroPCR demonstrate three major highlights of the Netrod® clinical trial: First, powerful blood pressure reduction. Compared to baseline, the primary endpoint showed that the RDN group's office systolic blood pressure dropped by 25.2 mmHg at six months, with 24-hour ambulatory systolic pressure falling 12.6 mmHg — a remarkably significant antihypertensive effect. Second, high achievement rates. At six months post-procedure, the office SBP target achievement rate was 64.7% in the RDN group versus 7.7% in the control group, a statistically significant difference with no device-related serious adverse events, indicating excellent safety. Third, high response rates. The response rate for blood pressure reduction exceeding 5 mmHg reached 93.4%, and for reductions above 10 mmHg, 89% — notably higher overall response rates compared to comparable studies. The results are truly exciting. Moreover, this represents original RDN clinical research from China, fully demonstrating Chinese innovative spirit and original capabilities, and will greatly advance RDN therapy in clinically appropriate hypertensive populations in China."

At this pivotal moment, the study's principal investigator, Professor Yujie Zhou from Beijing Anzhen Hospital, Capital Medical University, engaged in an in-depth dialogue with MedSpectrum Academic.

The Far-Reaching Harm of Hypertension: Prevention and Control Remain a Long Road

Q1

This year's World Hypertension Day theme is "Precise Measurement, Effective Control, Longevity and Health." Given the current situation — nearly 1.28 billion adults worldwide have hypertension, awareness is only 54%, over 700 million hypertensive patients are untreated, and merely 21% of adults with hypertension have their blood pressure controlled — what do you believe are the reasons for these low control and target achievement rates? What harms result from hypertension remaining uncontrolled?

Yujie Zhou: Hypertension prevention and control represent a very real challenge for China, as well as an issue of international concern. The low control rate is deeply troubling for cardiovascular physicians.

In China, the late president of Beijing Anzhen Hospital, Academician Yingkai Wu, began focusing on hypertension prevention and control while participating in international clinical trials. He extensively conducted epidemiological surveys among hypertensive patients in factories and communities to improve awareness and medication adherence rates. However, with changes in dietary patterns — high-salt diets, lifestyle pace, sleep patterns, and other factors — hypertension incidence remains stubbornly high. The current treatment landscape can be summarized as "one high, three lows": high prevalence alongside low awareness, treatment, and control rates. Multiple factors contribute to this situation. Principally, many patients have never had their blood pressure measured and are unaware of elevated readings. After hypertension diagnosis, some take antihypertensive medications without achieving target levels, resulting in persistently low control and achievement rates in China.

Hypertension is known as the silent killer — the most significant chronic disease threatening human health. Many patients experience no symptoms whatsoever, discovering the condition only during chance physical examinations or blood pressure measurements. Yet sustained, uncontrolled hypertension over time damages target organs including the heart, brain, and kidneys. Regarding cardiac damage, hypertension-induced coronary artery damage can trigger coronary heart disease, angina, and myocardial infarction, while direct damage to the heart itself leads to left ventricular hypertrophy and cardiac dilation. For cerebral damage, hypertension causes acute cerebrovascular events such as cerebral hemorrhage and cerebral infarction. Epidemiological data indicates that approximately 70% of annual stroke deaths and about 50% of myocardial infarctions in China are closely associated with hypertension. Meanwhile, hypertension causes chronic kidney damage, potentially progressing to renal insufficiency or uremia, with kidney damage further exacerbating elevated blood pressure. Additionally, hypertension damages retinal arteries, causing retinopathy and even blindness.

Therefore, hypertension prevention and treatment brook no delay; effective blood pressure control carries immense significance.

RDN Research Results Encouraging, Offering a Third Option for Hypertension Treatment

Q2

Beyond lifestyle improvements and pharmacological treatment, non-pharmacological hypertension therapy has become a research hotspot, with RDN representing the most important advance in minimally invasive interventional treatment. Your research team has conducted extensive studies in this area. What prospects do you see for RDN therapy in non-pharmacological hypertension treatment?

Yujie Zhou: Hypertensive patients, particularly those with cardiovascular, cerebrovascular, or renal complications, require lifelong medication, often with combination therapy. In clinical practice, there indeed exist patients whose blood pressure remains uncontrolled despite multiple antihypertensive medications, as well as those who are non-compliant or intolerant. For such patients with refractory hypertension, clinicians have persistently sought treatment modalities beyond medication that can achieve long-term, stable blood pressure control, pursuing this through unremitting exploration and research.

In the last century, surgical procedures discovered that sympathetic ganglionectomy could treat refractory hypertension and hypertensive crises, pioneering renal sympathetic denervation for hypertension treatment. However, clinical implementation was limited due to side effects from excessive blood pressure reduction. RDN refined this approach through minimally invasive intervention, employing safer radiofrequency methods to improve upon renal sympathetic nerve ablation outcomes. Through a series of clinical trials, it has inaugurated the global era of RDN treatment for hypertension.

The Chinese original Netrod® mesh multi-electrode renal artery radiofrequency ablation system study for uncontrolled essential hypertension, presented at EuroPCR 2023, yielded truly exciting results. This provides both physicians and patients with an additional treatment option. Particularly for patients with poorly controlled hypertension on medication, this therapy enables rapid sympathetic denervation, effectively reducing blood pressure and preventing adverse outcomes such as acute heart failure and acute stroke. Beyond this, RDN therapy offers unique advantages in improving renal function and chronic obstructive sleep apnea syndrome, with future potential applications in chronic kidney disease and chronic heart failure — improving prognosis in these conditions by inhibiting sympathetic nervous activity.

Opening a New Chapter in RDN Treatment: Netrod® Chinese Original Debuts on the World Stage

Q3

Your team-led clinical trial of the Netrod® mesh multi-electrode renal artery radiofrequency ablation system for uncontrolled essential hypertension, presented at EuroPCR, delivered truly exciting results — with excellent efficacy, target achievement rates, and safety. What were the key success factors for this study? What are the future research directions for RDN?

Yujie Zhou: The success of the Netrod® mesh multi-electrode renal artery radiofrequency ablation system clinical trial stems primarily from three factors.

First, scientifically distinctive product design. The Netrod® system employs a unique three-dimensional controllable expandable basket with independent six-electrode, six-channel, and four-quadrant ablation capabilities. This enables comprehensive ablation across all quadrants, varying vessel diameters (3mm–12mm), and both branch and main vessels, creating a distinctive continuous energy field. During operation, the device provides real-time temperature-controlled intelligent feedback and protection. Compared to other products, this substantially enhances ablation efficiency and effectiveness. A single procedure averages approximately 40 minutes — short operative time with high ablation efficiency.

Second, RDN team collaboration and thorough pre-trial training. This multicenter clinical trial established an MDT multidisciplinary team, integrating clinicians licensed in structural interventions, radiofrequency procedures, and coronary PCI. Comprehensive training preceded the multicenter trial, following standardized clinical pathways to achieve precision at every procedural step. The negative results from numerous RDN clinical trials in recent years have provided valuable lessons and educational insights, making pre-trial team training extraordinarily significant.

Third, optimal patient selection. This trial selected patients aged 18–65 with active sympathetic tone and resting heart rates exceeding 70 beats per minute, excluding end-stage renal failure patients requiring dialysis. Appropriate patient selection proves particularly crucial for RDN therapeutic outcomes.

Going forward, RDN research will further expand indication ranges, conducting subgroup analyses of patients with hypertension-related comorbidities and further studying the long-term effects of sympathetic denervation. We will track cardiovascular and cerebrovascular event rates in these patients over 10, 20 years, or longer, hoping to ultimately achieve reductions in mortality and disability rates. As technology advances, more scientifically efficient interventional ablation catheters may be developed. We are currently collaborating with innovative scientists on related designs, which will certainly be realized in the near future, bringing benefits to patients.

RDN Calls for Multidisciplinary Collaboration; Systematic Development Imperative

Q4

How do you view RDN's development in China, and from which dimensions will systematic construction proceed?

Yujie Zhou: Given the enormous hypertensive population and substantial eligible patient pool, RDN procedure volume will develop very rapidly over the next five years. To better address disease treatment needs, systematic RDN construction is critically important. This multicenter clinical trial established an MDT multidisciplinary team, with clinicians licensed in coronary PCI, electrophysiology, and structural interventions collaborating alongside hypertension specialists, internists, and general practitioners to form a hypertension interventional treatment team. Going forward, RDN procedures will involve coordinated multi-departmental collaboration to further enhance efficiency, promote disciplinary development, and improve blood pressure target achievement rates through interventional procedures — benefiting more patients.

RDN system construction is urgently needed. Since late last year, the Heart Alliance has organized national experts to jointly initiate research-related training programs and an RDN expert scientific statement — unique in China and unprecedented in the interventional cardiology field. Additionally, we are establishing standardized RDN clinical pathways, conducting high-quality theoretical and practical training for clinicians, and promoting RDN therapy in a planned, effective manner. Meanwhile, hypertension intervention centers are being established regionally, with infrastructure development and database quality control to standardize procedure management and comprehensive patient care. Going forward, we will develop expert consensus and guideline standards to guide and promote this technology's development and popularization, ultimately enabling over 50 million patients with refractory hypertension and hundreds of millions with uncontrolled hypertension to benefit.

RDN treatment is a comprehensive issue. Screening and diagnosis from high-risk populations is challenging, and current clinical hypertension detection standards are inconsistent with diverse methodologies. I recommend measurement by specialized physicians using standardized protocols in hospitals, while also having appropriate, qualified blood pressure measurement tools at home. Once diagnosed, professional physician-prescribed pharmacological treatment and lifestyle intervention are needed, with RDN serving as an effective third non-pharmacological treatment option for hypertensive patients.

Vision

Every family and society should care for every hypertensive patient, while improving detection, diagnosis, and treatment standards to reduce adverse cardiovascular events — carrying profound significance for patients, families, and society. Here, where the land ends, the sea begins — we look forward to RDN therapy bringing patients with uncontrolled hypertension out of darkness.

The devices/technologies involved in this trial: Netrod® mesh multi-electrode renal artery radiofrequency ablation system, including the Netrod® mesh multi-electrode renal artery radiofrequency ablation catheter and radiofrequency ablation generator. This product is not yet approved for sale in China.

Professor Yujie Zhou

Beijing Anzhen Hospital, Capital Medical University

• Chief Physician, Professor, Doctoral Supervisor, Beijing Scholar
• Executive Vice President, Capital Medical University Beijing Anzhen Hospital
• Executive Vice Director, Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Academic Leader, National Clinical Key Specialty
• Outstanding Scientific and Technical Talent and Leading Talent in Health
• National-Level Candidate, "New Century Millions of Talents" Project
• Young and Middle-Aged Expert with Outstanding Contributions
• Lifetime Achievement Award, C3 (Complex Cardiovascular Catheter Therapeutics), United States
• Distinguished Fellow, FACC, FHRS, FSCAI, FESC
• President, Interventional Cardiology Committee, Chinese Medical Doctor Association
• President, Chronic Disease Prevention and Management Committee, Chinese Aging Well Association
• President-Elect, Geriatrics Branch, Chinese Association of Gerontology and Geriatrics
• Vice President, Cardiovascular Physicians Branch, Chinese Medical Doctor Association
• Standing Committee Member, Chinese Society of Cardiology, Chinese Medical Association

Source: MedSpectrum Academic

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