Venus Medtech Appoints Professor Martin B. Leon as Global Principal Investigator of Its New-Generation RDN System

On July 27, 2021, Venus Medtech (Hangzhou) Inc., a leading provider of comprehensive interventional heart valve therapy solutions in China, and its controlling subsidiary Renaly Ltd., announced that Professor Martin B. Leon, MD, a pioneer in the field of interventional cardiovascular devices, has been appointed as the Global Principal Investigator (PI) for its new-generation renal artery denervation (RDN) system.

Dr. Leon is currently Professor of Medicine at Columbia University Irving Medical Center (CUIMC) in New York. He is also Director of the Center for Interventional Vascular Therapy (CIVT), Director of the Cardiac Catheterization Laboratories and the Director of the executive board of the New York-Presbyterian University Hospital of Columbia and Cornell Heart & Valve Center. In addition, he is the founder and Chairman of the annual Transcatheter Cardiovascular Therapeutics (TCT) conference. As a leader in the field of cardiovascular interventions, Dr. Leon has participated in more than 50 clinical trials in his role as PI, and performed more than 10,000 operations.

In the field of RDN, Dr. Leon and his team have served as the PI in clinical trials for several innovative systems including Medtronic's Symplicity Spyral™ Renal Denervation System and ReCor Medical's Paradise™ Ultrasonic Denervation System, both of which were awarded Breakthrough Device Designation by the U.S Food and Drug Administration (FDA) in 2020.

The new-generation RDN system was developed by Renaly, the controlling subsidiary of Venus Medtech. Its exclusive Dual-Mode Ultrasound Technology (DMUT) Platform can achieve noncontact continuous ablation treatment with real-time ultrasound imaging, significantly reducing the occurrence of various issues such as insufficient nerve ablation or vascular damage caused by uncontrolled ablation. The delivery of accurate and efficient ablation shifts the treatment paradigm to more predictable outcomes and simplifies the procedure flow, ultimately enhancing the procedure's safety and efficacy.

Hypertension is one of the world's most common chronic diseases. About one-third of the adult population worldwide suffers from hypertension[1]. The number of people diagnosed with hypertension in China exceeds 330 million, ranking the country first worldwide in terms of the number of sufferers of the condition. Data from the China Hypertension Survey shows that the prevalence rate of hypertension among adults ≥18 years of age was 27.9% at the time of the survey (2012-2015), and has since continued trending upward. It is a contributor in 50% and 20% of cardiovascular disease morbidity and mortality respectively in China. Hypertension, independent risk factor of cardiovascular events, can lead to complications such as stroke, myocardial infarction, heart failure, renal insufficiency, as a result, the control and treatment of hypertension is beneficial in that it can decrease the risk of cardiovascular complications[2].

Dr. Leon said: "I'm delighted to be appointed the PI of Renaly's new-generation RDN system. Hypertension is one of the major risk factors for cardiovascular disease. The development of RDN therapy presents a novel and promising therapeutic option for patients with resistant hypertension and poor adherence to medication. Addressing the clinical pain points of incomplete or excessive ablation associated with first-generation systems, Renaly's ultrasound-based renal denervation system is expected to significantly improve safety and controllability by realizing even and controllable ablation while using real-time ultrasound imaging. We are looking forward to starting clinical trials as soon as possible."

Eric Zi, Founder, Executive Director and Managing Director of Venus Medtech said: "We will focus on developing new devices and procedures, bionics, image fusion technology and digital sensing in terms of our future medical technology portfolio, all of which we plan to deeply integrate with our therapeutic products. By doing so, we can provide a line-up of solutions that covers the entire therapeutic process end-to-end, encompassing the procedure itself as well as the pre-op and post-op portions of the treatment. Renaly can be seen as a model for how one can integrate new procedures and imaging, by combining image recognition navigation with ultrasound to provide an optimized technology-based therapy to hypertensive patients. We are pleased to welcome Dr. Leon as our Global Principal Investigator. This is not our first collaboration as he has been a member of our Global Advisory Board and plays a leading role in promoting technological innovation and product globalization. We believe that with Dr. Leon's rich experience in the field, the innovative RDN system will rapidly advance through clinical trials and deliver benefits to patients worldwide."

Reference

[1]. World Health Organization Report: A global brief on hypertension – silent killer, global public health crisis.

[2]. Chinese Circulation Journal, September, 2020, Vol. 35 No.9 (Serial No.267)