China-Originated EDN Technology Ushers in a New Era of Device-Based Treatment for Type 2 Diabetes
On July 23, the “Forum on Glucose and Lipid Metabolism and Innovative Translation” was held in Nanjing. The forum brought together experts and representatives from relevant disciplines across China to jointly discuss advances and innovative translation in the field of glucose and lipid metabolism, with a focus on integrating basic science with clinical practice and promoting shared innovation and translation.
Notably, the Academician Forum brought together a constellation of leading medical experts. Academicians Teng Gaojun, Ning Guang, Gu Ning, and Wang Guangji, along with Professors Zhao Jiajun, Guo Lixin, Wang Weiqing, and Weng Jianping, engaged in discussions on hot topics and cutting-edge technologies in the field of endocrinology.
Professor Teng Gaojun, Chair of the Forum, President of the Interventional Physicians Branch of the Chinese Medical Doctor Association, and Dean of Zhongda Hospital Affiliated to Southeast University, delivered an insightful academic report titled “Transluminal Sympathetic Denervation for the Treatment of Type 2 Diabetes: A Preliminary Study on Safety and Efficacy.”
In addition to academic sharing, the forum witnessed a major announcement of a groundbreaking innovation in China: the EDN (Endovascular Denervation for the Treatment of T2DM) technology. Academician Teng Gaojun from the Chinese Academy of Sciences, Professor Zhao Jiajun, current Chairman of the Endocrinology Branch of the Chinese Medical Association, Professor Weng Jianping, Honorary Chairman of the Diabetes Branch of the Chinese Medical Association, Professor Sun Zilin, Leader of the Endocrinology Discipline at Zhongda Hospital Affiliated to Southeast University, Professor Li Ling, Assistant to the President and Director of the Department of Endocrinology, Mr. Cao Hongguang, Chairman of BRATTEA, along with numerous on-site experts in endocrinology and interventional medicine, jointly attended the kickoff meeting for the clinical trial project of EDN in the treatment of T2DM.
What Is EDN Technology? What New Breakthroughs Can It Bring to the Treatment of Type 2 Diabetes? VCBeat (WeChat ID: vcbeat) reported on the forum’s content.
Diabetes, an age-old disease, has long been a stubborn threat to global public health. According to statistics, there are 463 million adults aged 20–79 worldwide living with type 2 diabetes. Based on current growth trends, the number of adult patients with type 2 diabetes globally is projected to exceed 700 million by 2045. Currently, the most widely used oral antidiabetic medication in clinical practice is metformin, which has been in use for nearly 70 years.
EDN has evolved from RDN, percutaneous renal artery denervation radiofrequency ablation (RDN,Renal Deneravation) have demonstrated promising prospects in the field of hypertension treatment. As early as 1948, surgeons discovered that resection of the abdominal sympathetic nerves could achieve blood pressure reduction. The exploration of renal denervation (RDN) has never ceased; with device iteration, technological advancements, and more precise selection of indications, clinical RDN projects both domestically and internationally have shown favorable outcomes in recent years.
Unlike renal denervation (RDN), which originated abroad and was subsequently followed by many Chinese scientists and enterprises, the endovascular denervation (EDN) research initiated by Academician Teng’s team, along with the multi-electrode ablation catheter system employed in the studies, were independently developed through domestic autonomous innovation by Academician Gaojun Teng’s team in collaboration with Chinese medical device companies. As early as 2014, Academician Gaojun Teng’s team began investigating the mechanisms of radiofrequency ablation for treating metabolic diseases through animal experiments. This related research was awarded the 2018 JVIR Editor's Award for Top Laboratory Investigation by the Society of Interventional Radiology (SIR).
In 2019, Academician Teng’s team initiated an exploratory clinical study. The results were published in 2021 in the Journal of Vascular and Interventional Radiology and received the 2021 JVIR Editor's Award for Outstanding Clinical Study.
This study confirmed the safety of EDN in the treatment of type 2 diabetes mellitus (T2DM) and provided preliminary validation of its efficacy. The data showed significant improvements in glycated hemoglobin (HbA1c) and HOMA-IR in patients after EDN procedure, with HbA1c decreasing by 1.9%, fasting blood glucose decreasing by an average of 5.3 mmol/L, and 2-hour postprandial blood glucose decreasing by an average of 6.5 mmol/L. Additionally, there was a marked reduction in insulin dosage and use of oral hypoglycemic agents among patients.
To date, 13 patients have been enrolled in this study. The surgical outcomes were favorable, and among those followed up for five years, blood glucose levels remained stable.
The launch of this EDN project marks a preliminary pilot study transitioning from the scientific research conducted by Academician Teng’s team to registrational studies. Building on the previously established safety and efficacy profile of EDN, the primary endpoint is set as glycated hemoglobin (HbA1c) at the 6-month follow-up, along with other outcome measures including the oral glucose tolerance test (OGTT), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), fasting plasma glucose (FPG), 2-hour postprandial glucose (2hPG), and C-peptide. The study will also continuously monitor the comprehensive effects on glucose lowering, lipid reduction, and weight loss.
The results of the preliminary studies on EDN are undoubtedly encouraging. Professor Sun Zilin, academic leader of the Department of Endocrinology at Zhongda Hospital Southeast University and host of this kickoff meeting, stated that breakthroughs in the field of endocrinology are often driven by external forces. He expressed full confidence and high expectations for this collaborative project between the Department of Interventional Radiology and the Department of Endocrinology.
Wu Jianping, Vice President of Anhui Provincial Hospital, stated: “Not resting on our laurels and boldly innovating is the mission entrusted to this generation of endocrinologists by the times. From the perspectives of theoretical innovation and the self-reliance of domestically produced medical devices, EDN technology holds pioneering significance and serves as a typical example of medical-engineering collaboration. The Department of Endocrinology and the Department of Interventional Radiology at Anhui Provincial Hospital will join hands to participate in this clinical project, making further efforts in both basic theoretical research and clinical outcomes.”
Zhao Jiajun, President of Shandong Provincial Hospital, stated: “We extend our gratitude to Academician Teng Gaojun from Zhongda Hospital, Southeast University, for leading us in joining the EDN project, and we appreciate the diligent efforts made by Academician Teng’s team in the early stages. Let us jointly launch an innovative therapeutic approach for patients with diabetes whose blood glucose levels are poorly controlled with medication. We aim to help more patients with diabetes benefit earlier and more effectively, while leveraging this innovative and groundbreaking initiative to bring about a transformation in diabetes treatment and collectively advance the development of endocrinology as a discipline.”
Professor Li Ling, Assistant to the President and Director of the Department of Endocrinology at Zhongda Hospital Affiliated to Southeast University, stated: “EDN therapy for type 2 diabetes is a novel international technology pioneered by President Teng Gaojun. Today marks the launch of this technology, with the hope that it will benefit more patients with type 2 diabetes by providing them with additional treatment options, while also ushering in a new era for interventional medicine and endocrinology.”
From RDN to EDN, it is not only an innovation by Chinese scientists but also an innovation in China’s medical device industry. Due to the late start of China’s medical device industry, the research and development of medical devices in China has often been a follower of international innovations.
Shanghai BRATTEA Medical Technology Co., Ltd., the Chinese enterprise responsible for developing the medical device used in Academician Teng Gaojun’s innovative clinical study on EDN, has chosen a path of global innovation, delivering a groundbreaking breakthrough worldwide in the treatment of type 2 diabetes.
Shanghai BRATTEA demonstrates the independent innovation capabilities of domestic medical device companies. Its self-developed, globally first-of-its-kind ablation catheter, featuring a six-electrode basket structure, achieves excellent wall apposition and efficient energy delivery, overcoming the challenge of arterial blood flow obstruction. Meanwhile, the ablation generator is equipped with an intelligent operating system that includes temperature monitoring, impedance measurement, and power control, enabling precise determination of ablation endpoints to ensure consistent and stable ablation outcomes.
Currently, BRATTEA’s renal denervation (RDN) product is nearing completion of its registrational clinical trials, demonstrating favorable blood pressure-lowering efficacy. The company plans to submit a registration application to the National Medical Products Administration (NMPA) by the end of 2022. The product received Breakthrough Device designation from the U.S. FDA in July 2021 and exhibits strong performance and ease of use, offering a new therapeutic option for hypertension management worldwide.
EDN is another flagship product from BRATTEA, following RDN. It aims to achieve breakthroughs in treatment and drive innovation in the discipline within the fields of hypertension and diabetes—chronic diseases in which the sympathetic nervous system plays a critical role in pathogenesis—thereby providing a solution for chronic metabolic diseases that are not adequately controlled by pharmacological therapy.
Meanwhile, as a company with an extensive R&D pipeline, BRATTEA has also established a strategic presence in the treatment of atrial fibrillation, heart failure, COPD, and other conditions. We look forward to BRATTEA delivering more breakthrough solutions to address significant unmet clinical needs.
