First Successful Case! Mednovo's Self-Developed Ultrasound RDN System Completes First Trial at Tianjin First Central Hospital

2025-09-04 17:41

Recently, the team led by Director Lu Chengzhi at Tianjin First Central Hospital successfully performed renal denervation (RDN) surgery on a patient with primary hypertension using the "Single-Use Renal Artery Ultrasound Ablation Catheter and Renal Artery Ultrasound Ablation System" independently developed by Mednovo Group Co., Ltd.

The clinical trial, led by Director Lu Chengzhi of Tianjin First Central Hospital, is being conducted across more than 20 centers nationwide. This prospective, multicenter, blinded, randomized controlled ultrasound RDN clinical trial (MIRACLE RDN Study) aims to validate the safety and efficacy of the product, with the goal of reducing the burden on patients and providing more options for hypertension treatment in China.

Background

Hypertension is the most prevalent non-communicable disease in China and is associated with the most severe cardiovascular and cerebrovascular complications. In recent years, the prevalence of hypertension among young and middle-aged populations has shown a more pronounced upward trend.

Currently, medication is the primary clinical approach for lowering blood pressure. Many patients require multiple antihypertensive drugs with different mechanisms of action to achieve target systolic and diastolic blood pressure levels. The use of excessive medications not only increases the financial burden on patients but also raises the risk of adverse drug reactions and inappropriate drug interactions.

With advancements in interventional techniques, catheter-based renal sympathetic ultrasound ablation has emerged as a new treatment option for primary hypertension.

Patient and Procedure Details

The patient is a 50-year-old female with a 6-year history of hypertension and no other comorbidities. She had been taking nifedipine (30 mg/day) and irbesartan (150 mg/day) for an extended period, but her blood pressure remained inadequately controlled at around 155/90 mmHg. After switching to a combination of valsartan and amlodipine, her blood pressure was rechecked following 28 days of consistent medication use. The average clinic blood pressure was 154/84 mmHg, and the 24-hour ambulatory blood pressure monitoring showed an average value of 142/81 mmHg. She was diagnosed with medication-resistant primary hypertension.

Following evaluation by the expert team, ultrasound renal denervation (uRDN) was recommended for her blood pressure control.

The procedure was performed via right femoral artery puncture. Renal artery angiography was conducted using a guide catheter, revealing: the left renal artery showed no significant stenosis, with an estimated diameter stenosis of 0%, a visual diameter of 5.5 mm, and a length of 25 mm. No severe calcification, significant tortuosity, or other abnormalities were observed. No accessory renal artery was present on the left side. The right renal artery main trunk showed an estimated diameter stenosis of 0%, a visual diameter of 5.5 mm, and a length of 10 mm. No severe calcification, significant tortuosity, or other abnormalities were observed. No accessory renal artery was present on the right side.

Left side

Right side

The patient subsequently underwent the procedure according to the randomized grouping results. The surgery was completed successfully, and the patient was returned to the ward in stable condition. No device deficiencies or adverse events occurred during the procedure.

Surgeon’s Comments

Director Lu Chengzhi stated: "As a minimally invasive, non-implantable device-based treatment for hypertension, RDN intervention offers advantages such as small incisions and rapid recovery. Mednovo’s renal artery ultrasound ablation catheter demonstrated excellent performance in terms of torque control, visibility, and wall apposition, while the renal artery ultrasound ablation system proved highly stable and user-friendly. These features facilitate comprehensive and complete ablation of the renal sympathetic nerves. We look forward to the early completion of Mednovo’s pre-market clinical research for this renal artery ultrasound ablation system, hoping it will benefit more patients with hypertension."

Introduction

Awarded the title of "Tianjin Distinguished Physician" in the inaugural selection, Dr. Lu serves as a Standing Committee Member of the Cardiovascular Physician Branch of the Chinese Medical Doctor Association and the Hypertension Branch. He is also the Chairman of the Cardiovascular Disease Branch of the Tianjin Medical Association, Vice President of the Cardiovascular Physician Branch of the Tianjin Medical Doctor Association, Executive Director of the Tianjin Heart Association, and Chairman of the Hypertension and Heart Failure Committee. Additionally, he is a Standing Committee Member of the Cardiovascular Health Branch of the China Healthcare Promotion Association.

Dr. Lu specializes in the diagnosis and treatment of coronary heart disease, hypertension, cardiomyopathy, arrhythmia, and other cardiovascular diseases. He is highly proficient in interventional techniques for coronary heart disease, valvular heart diseases, and various arrhythmias.

Introduction

Dr. Wang is a member of the Youth Committee of the 12th Cardiovascular Disease Branch of the Chinese Medical Association and a Youth Editorial Board Member of the Chinese Journal of Hypertension. She also serves as a Youth Committee Member of the Cardiovascular Disease Branch of the Tianjin Medical Association, and a member of the Cardiovascular Health Medicine Branch of the China International Exchange and Promotion Association for Healthcare, the Hypertension Professional Committee of the Tianjin Medical Doctor Association, and the Cardiac Critical Care Professional Committee of the Tianjin Medical Doctor Association.

Dr. Wang has led three projects funded by the Tianjin Municipal Education Commission and Health Commission. She has published over 30 papers as first author, several of which are indexed in SCI. She has received the Second Prize of the Tianjin Science and Technology Progress Award (Rank 3). Her expertise includes the diagnosis and treatment of refractory hypertension, coronary heart disease, cardiomyopathy, heart failure, and other cardiovascular diseases.