Jinjiang Electronics Receives NMPA Approval for Second-Generation Pulsed Field Ablation Catheter

Single-use magnetic positioning pressure monitoring pulsed electric field ablation catheter throughAblation Tip StructureThe innovative design enables the precise application of high-voltage pulse energy sources on target tissues. The product adopts a multi-electrode configuration in localized areas, enhancing the adaptability of the ablation tip to various complex and delicate tissue structures.Can display catheter position and tip pressure monitoring values in real time., effectively improving surgical efficiency and reducing the risk of cardiac perforation complications in patients.

This is Jinjiang ElectronicApprovedUpCity'sThe Second Self-developedPFAPulsed Field Ablation Catheter(The first paragraph isPulsedFA^® Single-use Cardiac Pulsed Field Ablation Catheter), and both are selectedNMPACreation of the Green ChannelNew Product: The launch of this catheter marks an important expansion of Jinjiang Electronic's product pipeline in the field of tachyarrhythmia.

# PulsedFA^®FocalPointCatheter

PulsedFA^® FocalPoint It is a product used for cardiac pulsed electric field ablation (PFA) innovative medical device, mainly used for treating cardiac arrhythmias and other heart diseases.

Product Features

• Multifunctional Integration:PulsedFA^® FocalPoint CatheterIntegrated 3D modeling, mapping, and pulsing/Integrated with radiofrequency ablation and pressure monitoringThis multifunctional design reduces the number of catheters used and punctures during surgery, improving the convenience and safety of the operation.

• Magnetic Positioning Navigation:The catheter, based on magnetic navigation technology, is able toReal-time display of catheter position and tip pressure monitoring values. This technology not only improves the precision of the surgery but also helps the surgeon more accurately select the ablation target.

• Tissue Selectivity and Safety:The ProductUtilizing the tissue selectivity of pulsed electric fields, it is able toPrecisely perform ablation on myocardial cells, without damaging the surrounding tissue. Moreover, its ablation process is non-thermal ablation, avoiding heat-related injuries.

• Ease of Operation:The catheter is made ofCircular Tip Design, which conforms to the operating habits of most doctors and has virtually no learning curve. The surgical procedure is simple, allowing doctors to quickly grasp the key points of operation.

Clinical Application and Advantages

• High Efficiency:The catheter can simultaneously perform modeling, mapping, ablation, and validation, reducing operation time and complexity.

• Low Radiation: During the surgical procedure, this catheter requires only a minimal amount of radiation during the interatrial septum puncture.XLine exposure, and close to zero radiation exposure for the rest of the time, significantly reducing radiation exposure for both medical staff and patients.

• Patients experience good: Due to its non-thermal ablation and tissue selectivity, patients experience...Almost no muscle twitch reaction, with good clinical experience.

# Relevant Clinical Trials

Electrophysiology Team of West China Hospital, Sichuan UniversityThe first human exploratory study was launched, and2023YearPublish the main research results inTop international journal in the field of arrhythmia, "JACC:EP》, the study isPFAProvides a new perspective in the clinical application of interventional treatment for arrhythmia.

This study led by Huaxi Hospital is a single-center, single-arm, prospective clinical trial, aiming toEvaluation PulsedFA^® FocalPoint Catheter in TreatmentAtrioventricular Nodal Reentrant Tachycardia (AVNRT) PatientSafety and Feasibility in China.

Research Methods

• Research Object: Included30Confirmed by electrophysiological examination asAVNRT The patients, with an average age of47.9Years.

• Treatment method: All patients were treated with PulsedFA^® FocalPoint Catheter for pulsed electric field ablation therapy.

• Evaluation Metrics:

  Primary Endpoint:Acute Ablation Success Rate。

  Secondary endpoints:Postoperative6Success Rate and Safety Events of Ablation Over the Months。

Research Results

• Acute Ablation Success Rate: All30All patients achieved acute ablation success.

• Operation Time: The average operation time is109.1Minute,XFluoroscopy time is4.1Minute.

• Number of Ablations: Median =8Sub-pulse Electric Field Ablation Application.

• Follow-up Results:Postoperative6months, all patients maintained sinus rhythm and no adverse events occurred.。

• Safety:During and after the ablation process6No serious complications were reported during the follow-up period of months.。

Research Conclusion

PulsedFA^® FocalPoint Catheter in TreatmentAVNRT Showed good feasibility and safety in patients.All patients achieved acute ablation success and postoperative6Months of maintaining sinus rhythm, with no adverse events reported。

# LEAD-Mapping^®3D Cardiac Electrophysiology Mapping System

This product can be used in conjunction with the magnetic localization mapping catheter and body surface reference electrode produced by our company, which have been approved for use with this product.Emitting electrical stimulation signals and recording electrocardiogram signals during cardiac electrophysiology procedures,For cardiac electrophysiological mapping, 3D modeling, and displaying catheter positions. It can also measure intracavitary and vascular pressures. Used in medical institutions.

Product Features

1. Adopting magnetic and electrical fusion positioning, with precise positioning accuracy.±1.0mm. Combined with Jinjiang Multi-Magnetic Catheter, full magnetic positioning of the catheter can be achieved.Accurately display catheter morphology;

2. With two respiratory learning technologies, respiratory compensation and gating, it can effectively shield the catheter motion interference caused by respiration, displaying the catheter motion posture in real time, stably and accurately, ensuring safe and efficient catheter operation while reducing radiation exposure.

3. The signal is true and clear,Accurately Present Characteristic Potentials;

4. Rapid modeling and synchronous dense point mapping to establish a true anatomical model;

5. Integrated with a complete electrophysiological recording system, automatic mapping module, ablation control analysis module, and multi-parameter adjustable stimulation module, achieving multifunctional integration;

6. Supports seamless integration with Jinjiang Electronic's self-developed radiofrequency ablation system and pulsed electric field ablation system, providing three-dimensional guided radiofrequency ablation.(RFA)+Pulsed Field Ablation Under 3D Guidance(PFA)A Variety of Comprehensive Solutions.

# Company Introduction

Jinjiang ElectronicFounded in 2002, headquartered in Chengdu, Sichuan,It is one of the few companies in China with a complete line of cardiac electrophysiology products, capable of providing coverage for cardiac electrophysiology procedures.“Mapping, Modeling, Ablation, Validation”The full-process equipment and consumables product portfolio.

Since its establishment, the company has gradually built up through independent research and development.3DPFATreatment PlanA product series at the core.

The core products of the company include a magnetic and electric positioning three-dimensional mapping system, cardiac pulse field ablation equipment, and accompanying catheters. In addition, the company's product range covers multi-channel physiological recorders, radiofrequency ablation devices, radiofrequency ablation catheters, and access consumables, among other cardiac electrophysiology products. The product portfolio is relatively comprehensive, providing complete solutions for patients with tachyarrhythmia. Meanwhile, the company’s product line extends to the field of pain management, meeting more diversified clinical needs.

Financing History

• 2021Year12To2022Year8During the month, Jinjiang Electronic completedAWheel andBRound of financing, with cumulative financing exceeding7RMB billion, with investors including Hillhouse Capital, Xinda Kunpeng, Guanghua Wutong, Yuanheng Lizhen, Weigao Group, Huimei Capital, etc. This isThe Largest Scale Primary Market Transaction in the History of China's Electrophysiology Industry。

• 2022Year6Month12On [date], Jinjiang Electronic submitted its prospectus to the STAR Market, planning to raise funds.26.91100 million yuan。

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