DeJin Medical's DragonFire Transcatheter Myocardial Radiofrequency Ablation System Enters China's Innovative Medical Device Fast-Track Review

Apr 27, 2024 10:05 CST Updated 10:05

Valgen Medtech

Minimally Invasive Interventional Device Developer

Source of the article: Heart Future; Editor: Seven Kite

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently, the Medical Device Technology Evaluation Center of the National Medical Products Administration released "Public Notice of the Review Results for the Special Review Application of Innovative Medical Devices (No. 4, 2024)》, wherein,Valgen Medtech Co., Ltd.Self-developedTranscatheter Radiofrequency Ablation SystemHas passed the review and entered the "Green Channel" for special review of innovative medical devices.。

DragonFire Myocardial Radiofrequency Ablation SystemAdoptTransfemoral ApproachThe method involves inserting the ablation needle through the endocardium into the hypertrophic interventricular septum myocardium for ablation, thereby reducing the thickness of the interventricular septum myocardium and improving LVOT obstruction.The system can accurately predict the ablation range.，No serious complications such as non-traumatic overflow, conduction damage, or low cardiac output after surgery, which are commonly seen in traditional alcohol ablation or surgical procedures.。

# Radiofrequency Ablation for Cardiac Arrhythmias

Radiofrequency Ablation for Cardiac Arrhythmias is Commonly Used to TreatPre-excitation Syndrome, atrial flutter, atrial tachycardia and other arrhythmias,It is a surgical procedure that uses electrodes to treat easily excitable myocardial tissue, preventing its automatic excitement from causing arrhythmia.。

Arrhythmia refers to any change in the heart's normal rate or rhythm., Occurs due to changes in the generation or conduction of electrical activity within the myocardium. In a healthy heart, the sinoatrial node acts as the pacemaker, generating electrical impulses that then conduct through the atria to the ventricles, hence it is referred to as "Sinus Rhythm". The sinoatrial node, atrioventricular node, atrioventricular bundle, and Purkinje fibers act as the network for cardiac electrical conduction, stimulating heartbeats and maintaining the normal operation of the human blood system.

Cardiac ablation technology requires the insertion of a catheter through the groin or neck area.. The electrodes at the tip of the catheter can help doctors detect electrophysiological characteristics and determine the location of abnormal electrical signals. Once the precise location is identified, the doctor canAblation of a localized area by delivering energy through a catheter。

The commonly used ablation technologies can be divided into traditional radiofrequency ablation and cryoablation; the latest emerging ablation technology is pulsed electric field ablation.The fundamental principle of radiofrequency ablation is hyperthermia.Radiofrequency is a high-frequency electromagnetic wave composed of alternating electric and magnetic fields. The energy generated by radiofrequency waves in the range of 375kHz to 500kHz travels from the transmitter to the treatment electrode needle and forms a closed circuit in the human body via the negative electrode plate.Charged ions and charged colloids vibrate at high speed, collide, and rub against each other under the action of an alternating electric field formed by radiofrequency, generating heat that raises the tissue temperature and causes coagulative necrosis.。

Radiofrequency AblationSimple operation, minimal trauma, short surgery time, low infection risk, fast wound healing. The main approaches are percutaneous puncture, laparoscopy, and open abdominal radiofrequency ablation under the guidance of relevant imaging techniques. Currently, the most commonly used imaging guidance methods are, in order, B-mode ultrasound and CT.The range of radiofrequency current injury introduced into the cardiac cavity via catheter is 1-3mm, which does not cause harm to the body.。

With the increase in the global elderly population, the demand for the radiofrequency ablation market is also increasing and is expected to maintain growth in the coming years. The global radiofrequency ablation market size reached approximately USD 2 billion in 2019.It is expected to grow to approximately USD 4 billion by 2027, with an annual compound growth rate of 8.5%.。

The growth of the radiofrequency ablation market is also driven by the following factors: Continuous improvements in radiofrequency ablation technology have made treatments more precise and safer; this technology is not only applicable to the treatment of heart diseases but also effective for treating various conditions in the liver, lungs, kidneys, and more, broadening its application scope in the market; support and promotion of radiofrequency ablation technology by governments and medical institutions have further driven market growth.

The downstream application fields of radiofrequency ablation include radiofrequency ablation catheters, radiofrequency ablation generators, radiofrequency ablation probes, and radiofrequency ablation systems.。The radiofrequency ablation catheter is the core product of radiofrequency ablation technology., used to deliver high-frequency current to the tissue that needs treatment, generating thermal energy to destroy or excise the tissue.Radiofrequency Ablation GeneratorIt is the key equipment of radiofrequency ablation technology, used to generate high-frequency current and provide energy for the catheter.Radiofrequency Ablation ProbeIt is part of a radiofrequency ablation catheter used to deliver high-frequency current to the tissue.Radiofrequency Ablation SystemIt is a set of equipment composed of radiofrequency ablation catheters, radiofrequency ablation generators, radiofrequency ablation probes, etc., used for performing radiofrequency ablation therapy.

# DragonFire Myocardial Radiofrequency Ablation System

▲DragonFire Myocardial RF AblationIntegrated System, Transcatheter Myocardial Radiofrequency Ablation Needle and Its Guidance System

DragonFireAnd its innovative surgical techniques byNuochin Medical (a wholly-owned subsidiary of Valgen Medtech)Innovative R&D, jointly researched with Professor Fang Zhenfei's team from the Second Xiangya Hospital of Central South University。

DragonFire byDragonFire Myocardial Radiofrequency Ablation System, Transcatheter Myocardial Radiofrequency Ablation Needle and Its Guidance SystemComposition.Only requires minimally invasive intervention.Transfemoral Approach, the ablation needle is inserted through the endocardium into the hypertrophic interventricular septum myocardial site for ablation, thereby reducing the thickness of the interventricular septum myocardium and improving LVOT obstruction. The ablation range can be accurately predicted without complications such as damage overflow, conduction damage, or low cardiac output after surgery, which are common severe complications in traditional alcohol ablation or surgical procedures.

DragonFire integrates the advantages of no thoracotomy, fast efficacy, fewer complications, minimal invasiveness, and precise controllable ablation range.And many other technical advantages。The company has accumulated relevant experience in the early stage regarding patient selection, formulation of surgical strategies, and operation and mastery of procedures and systems.Multicenter registered clinical trials across China are also about to begin.`, looking forward to the day when this innovative technology will benefit a large number of patients.`

# Exploratory Clinical Application

In December 2023, Professor Fang Zhenfei's team from the Second Xiangya Hospital of Central South University once again utilized the DragonFire myocardial radiofrequency ablation system, the transcatheter myocardial radiofrequency ablation needle, and its guidance system (hereinafter referred to as "DragonFire") to perform intramyocardial radiofrequency ablation in treating a patient with obstructive hypertrophic cardiomyopathy (oHCM). Thus far,Valgen Medtech's DragonFire Exploratory Clinical Trial Officially Completes 10th Clinical Implant。

DragonFire Exploratory Clinical Trial is conducted by Valgen Medtech Co., Ltd., a wholly-owned subsidiary of Hangzhou Valgen Medtech Co., Ltd.Valgen Medtech Co., Ltd. (hereinafter referred to as "Valgen Medtech") conducts, byProfessor Fang Zhenfei from the Second Xiangya Hospital of Central South University serves as the Principal Investigator of the early exploratory clinical study., inCompleted the world's first clinical application in humans and the first enrollment in an exploratory clinical trial in October 2022。

Since the trial began, 10 surgeries have been successfully completed.The surgical procedure was performed smoothly during the operation, the system operated steadily, and the expected results were achieved after the surgery.。6-Month Clinical Follow-Up Data Shows Significant Improvement in Patient's Cardiac Function, effective in treating patients with obstructive hypertrophic cardiomyopathy.

▲Source of the imageXiangya Second Hospital of Central South University

Follow-up data from the first 9 patients showed that the average peak LVOTG at baseline, before discharge, at 30 days post-operation, at 3 months post-operation, and at 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, respectively.

The trial results preliminarily verified the feasibility and safety of DragonFire in treating obstructive hypertrophic cardiomyopathy.. Expected to inject a new solution into the current treatment of hypertrophic cardiomyopathy in China.

▲Average Peak LVOTG of Subjects at Different Time Intervals

# Clinical Application Cases

(1) Patient Details

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.

The patient's echocardiogram showed: LVEDD 42mm, LAD 36mm, EF 65%. There was non-uniform significant thickening of the interventricular septum, with a maximum thickness of 22mm, and the left ventricular posterior wall thickened to 14mm.Left Ventricular Outflow Tract Obstruction (Severe), SAM sign positive.With mild regurgitation of the mitral and tricuspid valves, calcification of the aortic valve and mild regurgitationThe systolic flow velocity of LVOT was significantly increased, approximately 6.1 m/s, with a PGmax as high as 150 mmHg.

(II) Surgical Procedure

Preoperative, the technical team utilized 3D reconstruction technology to customize an instrument approach tailored to the anatomical characteristics of the patient's disease, accurately identifying the hypertrophic area. They then simulated the ablation path.Plan to consecutively ablate 8 sites, the required ablation energy range and depth at various points were estimated preoperatively, and determined.Ablation Strategy from Anterior Septum to Posterior Septum。

IntraoperativeProf. Fang Zhenfei skillfully operated the DragonFire, following the preoperative ablation strategy. He continuously performed precise positioning and puncture on the thickest myocardial regions of the anterior and middle septal base, and carried out ablation within the corresponding energy range.

Postoperative, Color Doppler Ultrasound IndicatesDisappearance of SAM Sign，Mitral Regurgitation Improvement, LVOT systolic flow velocity decreased from 6.1 m/s preoperatively to 2.1 m/s postoperatively, and the peak pressure gradient of the left ventricular outflow tract dropped from 150 mmHg preoperatively to 17 mmHg postoperatively.Immediate Ablation Effect During SurgeryResulting in a reduction of outflow tract gradient by up to 133 mmHg.

The patient was extubated immediately after the surgery.Clinical symptoms significantly improved, with no adverse effects.For example, arrhythmia, low left heart output, etc. after oHCM surgeryCommonComplicationsThe patient was discharged smoothly one week after the surgery.

▲Source of the imageXiangya Second Hospital of Central South University

# About Valgen Medtech

Valgen Medtech Co., Ltd. focuses onInterventional Treatment of Structural Heart DiseaseField, founded in Hangzhou in 2015,PublicThe company's headquarters is located in the National High-tech Industrial Development Zone (Binjiang District), Hangzhou, China, with an additional innovation and R&D center in Shenzhen.By the end of 2023, the company had filed over 500 patent applications globally, with more than 150 already granted.。Three Self-Developed Innovative Products Pass the NMPA's Special Review Process for Innovative Medical DevicesThe multiple interventional treatment devices represented by the Dragon series have enriched clinical options in China's structural heart disease treatment field.

Among them, the DragonFly™ Transcatheter Mitral Valve Clip System, asChina's First Self-Developed Transfemoral Venous Approach Edge-to-Edge Repair Product, which passed the special review procedure for innovative medical devices by the NMPA in March 2021, and was officially approved by the NMPA for marketing in China on November 29, 2023. The product is supported by the national "14th Five-Year Plan" key research and development program. In addition,Products currently on the market includeSister Pu™ Medical Radiation Protection Screen, Magpie™ Balloon Dilation Catheter, DragonPath™ Atrial Septal Puncture System, and Firework™ Guidewire Series, among other products.

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