Ruixin Medical Initiates Pivotal Clinical Trial for Intracardiac Echocardiography (ICE) System and Disposable ICE Catheter
RaysightMed
Medical Imaging Product Developer
RaysightMedIntracardiac Ultrasound DiagnosisThe System and Single-Use Intracardiac Echocardiography Catheter have officially launched the pre-market clinical trial, with the kick-off meeting held at the First Affiliated Hospital of Jinan University. The product has successfully completed the first pre-market clinical application in China, and its effectiveness has been highly recognized by clinical experts. Professor Guo Jun from the First Affiliated Hospital of Jinan University and Ma Jun, Co-founder and Chief Technology Officer of RaysightMed, attended the meeting. The event brought together numerous experts in cardiology and ultrasound to discuss the product’s functional advantages as well as its methods and value in clinical applications.
Expert Evaluation:
Enhance Surgical Safety, Hoping the Product Will Be Applied Worldwide
The clinical research project is led by Professor Guo Jun from the Cardiology Department of the First Affiliated Hospital of Jinan University, who stated at the launch meeting: "Intracardiac Echocardiography (intracardiac echocardiography，ICE) Has the advantages of real-time imaging, real-time monitoring of intraoperative complications, and good tolerance.，In recent yearsIncreasinglyShouldUsed for various types of cardiac interventional procedures.RaysightMedIntracardiac Ultrasound DiagnosisSystemAndICE Catheter, canFull visualization, precise display of local anatomical structures, cardiac blood flow, and blood flow velocity characteristics.，Well meets clinical needs。Hope the clinical trial of RaysightMed's intracardiac echocardiography diagnostic system and disposable intracardiac echocardiography catheter will be successfully completed, and be used in clinical practice as soon as possible, striving to promote the product throughout China and even the world at an early date.”
Professor Guo Jun from the Department of Cardiology, First Affiliated Hospital of Jinan University, delivered a speech.
Product Layout:
From Coronary Intervention to Electrophysiology and Structural Heart Fields
Create Precision Diagnosis and Treatment Solutions for Heart Disease
RaysightMed Co-Founder and CTO Ma Jun Addressed:RaysightMed Intracardiac Echocardiography Diagnostic SystemAndICE CatheterThe launch ofRaysightMed's product portfolio has expanded from the coronary intervention field to electrophysiology and structural heart fields, committing to provide precise cardiac diagnosis and treatment solutions for clinical practice.RaysightMed's greatest vision is to create more precise, efficient, and safe products for doctors, bringing greater benefits to patients. We believe that with the support of Professor Guo, all experts, and partners, this trial will achieve complete success!”
During the product introduction session, Li Jing, Product Manager of RaysightMed, introduced that the RaysightMed Intracardiac Ultrasound Diagnosis System includes colorDoppler Ultrasound HostSonusHub and the disposable intracardiac echocardiography catheter SonusGuideComposed of two parts, it can be applied in electrophysiology and structural heart surgeries. ICE plays a significant role in real-time observation of intracardiac anatomy, guidance for atrial septal puncture, monitoring pericardial effusion, and more. The RaysightMed Color Doppler Ultrasound System SonusHub utilizes cutting-edge ultrasound imaging technology. Compared to mainstream ICE systems, it ranks among the top tier in terms of sector angle, imaging depth, frequency range, and imaging modes. RaysightMed's disposable intracardiac echocardiography catheter SonusGuide ICE...The outer diameter is divided into two models: 8F and 10F.The deflectable catheter adopts the cutting-edge technology of 6-segment tube integrated fusion, achieving a maximum deflection angle of 180°, leading the industry..The ultrasonic transducer adopts a 64-element ultrasonic transducer made of the most advanced piezoelectric material, ensuring ultra-high clarity and extreme depth of the ultrasonic image.
RaysightMed Product Manager Introduces Raysight Intracardiac Ultrasound Diagnostic System
First Enrolled Case：
Helping complex case diagnosis to be more accurate and safer
The first patient enrolled in this trial is male,At 73 years old, the patient reports being previously healthy, denying a history of hypertension, diabetes, or hyperlipidemia. The main reason for this hospital admission is "recurrent chest tightness and chest pain for one year, aggravated over the past two weeks." The preliminary consideration is "investigation of chest pain: high possibility of coronary heart disease." Admission tests showed: 1. Electrocardiogram (ECG): Sinus bradycardia, T-wave changes, pathological Q waves in inferior leads; 2. Echocardiography suggested: left atrial enlargement, left ventricular enlargement, severe mitral regurgitation, ejection fraction 50%; 3. Selective coronary angiography performed on schedule showed: right-dominant type, no significant stenosis in the left main coronary artery (LM), plaque formation in the proximal and middle segments of the left anterior descending artery (LAD), antegrade blood flow TIMI grade 3; no significant stenosis in the left circumflex artery (LCX), antegrade blood flow TIMI grade 3; 50% stenosis in the proximal segment of the right coronary artery (RCA), antegrade blood flow TIMI grade 3. Coronary angiography showed no significant coronary stenosis, and ischemia is currently not considered to be the cause of left heart enlargement. The necessity of performing percutaneous myocardial biopsy was explained to the family. The patient and family agreed to proceed with percutaneous myocardial biopsy for further diagnosis. Under the guidance of RaysightMed's intracardiac echocardiography diagnostic system and ICE, the shaped tip of the sheath was inserted into the interventricular septum of the right ventricle through the right femoral vein. ICE precisely located the biopsy forceps. ICE observations before and after the procedure showed no significant change in the amount of pericardial effusion, and the myocardial biopsy under ICE guidance was successfully completed.
Postoperative,Professor Lan Xianwu, Department of Cardiology, First Affiliated Hospital of Jinan UniversityRepresentation:"RaysightMed's Developed Intracardiac Ultrasound Catheter SonusGuideExcellent imaging quality and good bending performance, combined with the SonusHub color Doppler ultrasound systemEnhance surgical safety, green electrophysiology can also reduce the radiation exposure for doctors, and help diagnose complex diseases more accurately, safely, and efficiently.。”
In the future, RaysightMed will continue to focus on technological innovation and clinical needs, providing patients and doctors with more comprehensive cardiovascular and cerebrovascular solutions.AI + Surgical Robot Precision Diagnosis and Treatment Solutions: Enabling Earlier Diagnosis and More Accurate Treatment for Every Cardiovascular Condition.
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