DragonFire Transcatheter Myocardial Radiofrequency Ablation System Completes 10-Case Feasibility Clinical Trial for Obstructive Hypertrophic Cardiomyopathy

Changsha, China.Professor Fang Zhenfei's Team from the Second Xiangya Hospital of Central South UniversityThe DragonFire myocardial radiofrequency ablation system, trans catheter myocardial radiofrequency ablation needle, and its guidance system (hereinafter referred to as "DragonFire") were applied again to perform intramyocardial radiofrequency ablation for the treatment of a patient with obstructive hypertrophic cardiomyopathy (oHCM). Thus far,DragonFire Exploratory Clinical Trial Officially Completes the 10th Clinical Implant.

The DragonFire exploratory clinical trial was conducted by Hangzhou Nuoqin Medical Instrument Co., Ltd. (hereinafter referred to as "Nuoqin Medical"), a wholly-owned subsidiary of Valgen Medtech Co., Ltd. Professor Zhenfei Fang from the Second Xiangya Hospital of Central South University served as the principal investigator for the early exploratory clinical study. In October 2022, the trial completed the world's first human clinical application and enrolled its first patient in the exploratory clinical trial. Since the initiation of the trial, 10 surgeries have been successfully completed, with smooth intraoperative procedures, stable system operation, and postoperative results meeting expectations.Six-month clinical follow-up data show significant improvement in cardiac function, effectively treating patients with obstructive hypertrophic cardiomyopathy.

Professor Fang Zhenfei's Team and Technical Team Photo

Professor Fang Zhenfei's Team in Intraoperative Operation

Follow-up data from the first nine patients showed that the average peak LVOTG at baseline, before discharge, 30 days post-operation, 3 months post-operation, and 6 months post-operation were: 74.78±30.47mmHg, 37.22±30.4mmHg, 25.63±14.24mmHg, 23.33±17.83mmHg, and 21.00±9.00mmHg. The trial results preliminarily verified the feasibility and safety of DragonFire in treating obstructive hypertrophic cardiomyopathy. This is expected to introduce a new treatment option for existing hypertrophic cardiomyopathy therapies in China.

Changes in Peak LVOTG at Rest Postoperatively in the FIM Study

First FIM Group Photo on October 13, 2022

The patient is a 65-year-old female who experienced worsening chest tightness and shortness of breath accompanied by paroxysmal nocturnal dyspnea one year ago. Symptoms were not relieved after drug treatment. Echocardiography showed: LVEDD 42mm, LAD 36mm, EF 65%. There was non-uniform significant thickening of the interventricular septum, with the thickest part measuring 22mm, left ventricular posterior wall thickened to 14mm, severe left ventricular outflow tract obstruction (LVOTO), and positive SAM sign. Mild regurgitation of the mitral and tricuspid valves, calcification of the aortic valve with mild regurgitation. LVOT systolic velocity significantly increased to approximately 6.1m/s, with PGmax reaching 150mmHg.

Preoperatively, the technical team utilized three-dimensional reconstruction technology to customize an instrument approach tailored to the patient's disease anatomy, accurately identifying the hypertrophic regions. They then simulated the ablation pathway, planning for continuous ablation at eight sites. The preoperative assessment estimated the ablation energy range and depth required for each site, establishing an ablation strategy from the anterior septum to the posterior septum.

During the surgery, Professor Fang Zhenfei skillfully manipulated DragonFire, following the ablation strategy determined pre-operation. He consecutively conducted precise localization and puncture on the thickest myocardial areas of the anterior and middle septal base, performing ablations with corresponding energy levels.

Postoperative color Doppler ultrasound indicated the disappearance of SAM sign and improvement in mitral regurgitation.LVOT systolic velocity decreased from 6.1 m/s preoperatively to 2.1 m/s postoperatively.The peak pressure gradient of the left ventricular outflow tract decreased from 150 mmHg preoperatively to 17 mmHg, with an immediate ablation effect during the procedure resulting in a reduction of the outflow tract pressure gradient by as much as 133 mmHg.

The patient was extubated immediately after the surgery, with significant improvement in clinical symptoms and no common post-oHCM complications such as arrhythmia or low cardiac output of the left heart. The patient was discharged smoothly one week after the surgery.

DragonFire Myocardial Radiofrequency Ablation System, Transcatheter Myocardial Radiofrequency Ablation Needle and Its Guidance System

DragonFire and its innovative surgical technique were developed by Hangzhou Nuoqin Medical Instrument Co., Ltd. in collaboration with Professor Zhenfei Fang's team from the Second Xiangya Hospital of Central South University. The procedure involves a minimally invasive approach through the femoral artery, where an ablation needle is inserted via the endocardium to target the hypertrophic interventricular septum for ablation. This reduces the thickness of the interventricular septal muscle and alleviates LVOT obstruction. It allows for precise prediction of the ablation area without complications such as collateral damage, conduction system injury, or postoperative low cardiac output, which are commonly associated with traditional alcohol ablation or surgical procedures.

DragonFire integrates multiple technical advantages such as no thoracotomy, fast efficacy, fewer complications, minimal invasiveness, and precise controllable ablation range. Relevant experience has been accumulated in the preliminary selection of patients, formulation of surgical strategies, and operation and mastery of procedures and systems.Multicenter registered clinical trials across China are also about to begin, with the hope that this innovative technology will soon benefit a large number of patients.

Valgen Medtech Co., Ltd. (hereinafter referred to as "Valgen Medtech") focuses on the field of interventional treatment for structural heart disease. Established in Hangzhou in 2015, by the end of 2023, the company has filed over 500 patent applications globally, with more than 150 already granted. Three innovative products independently developed by the company have passed the special review process for innovative medical devices by the pharmaceutical regulatory authority. The Dragon series and other interventional treatment devices will also greatly enrich clinical options in China for the treatment of structural heart disease.

Among them, the DragonFly™ Transcatheter Mitral Valve Clip System, as the first China-developed transvenous edge-to-edge repair product in China, passed the NMPA Innovative Medical Device Special Review Process in March 2021 and received NMPA approval for official market launch in China on November 29, 2023. The product is supported by the national "14th Five-Year Plan" key research and development program. In addition, currently marketed products include Sister Pu™ Medical Radiation Protection Screen, Magpie™ Balloon Dilation Catheter, DragonPath™ Atrial Septal Puncture System, and Firework™ Guidewire Series, among others.

The company's headquarters is located in Hangzhou National High-tech Industrial Development Zone (Binjiang District), China, with an additional innovation research and development center in Shenzhen. The enterprise has been successively recognized as a national and Zhejiang provincial technology-based small and medium-sized enterprise, a Hangzhou high-tech research and development center, and a Hangzhou engineering research center. In the future, Valgen Medtech will adhere to the corporate development strategy of "rooted in China, facing the world," accelerate the incubation of more self-developed devices that address domestic clinical pain points, spare no effort in promoting clinical applications, and provide better treatment solutions for patients in China and even globally.