Zhenyi Medical's TruDelta® Transcatheter Mitral Valve System Enters China's Innovation Review Pathway

# About Mitral Valve Disease

The mitral valve is located between the left atrium and the left ventricle, serving as the anatomical landmark that separates the left atrium and the left ventricle. Its primary function is to ensure that blood flows from the left atrium into the left ventricle during diastole and does not reflux back into the left atrium during systole.Mitral valve disease mainly includes mitral regurgitation and mitral stenosis, among which mitral regurgitation is one of the most common types of heart valve diseases.Overview of the Disease and Illustration are as follows.

The mitral valve is located within the opening between the left atrium and the left ventricle.. The opening of the mitral valve allows blood from the left atrium to fill the left ventricle, and when the left ventricle contracts, the mitral valve closes to ensure that the pumped blood flows only into the aorta and not back into the left atrium. When the mitral valve does not close completely, some blood leaks back into the left atrium, which is referred to as mitral regurgitation.Moderate to severe mitral regurgitation can lead to increased blood flow and elevated pressure in the left atrium.May cause pulmonary hypertension, pulmonary edema, atrial fibrillation, heart failure, and even death.。

# TruDelta® Transcatheter Mitral Valve System

Product Name: TruDelta Transcatheter Mitral Valve System

Product Introduction: TruDelta Transcatheter Mitral Valve System, its valve adoptsD-shaped Stent + Apical Anchoring Mechanism, The valve is available in multiple specifications, covering the needs of the vast majority of patients;Double-layer Stent Design, the outer stent is designed in a D-shape to better fit the native valve annulus, with biomaterials sutured onto the inner stent;The apex fixator is available in two sizes: large and small.The part of the fixator that adheres to the epicardium is covered with polymer material, providing anchoring force to the valve while helping to seal the apical wound.The delivery system features an integrated design for valve loading, deployment, and retrieval., multiple traction adjustment modes,Can achieve valve retrieval and repositioning as needed.

Product Positioning: The TruDelta Transcatheter Mitral Valve System adopts the first domestically produced apical access and apical fixation valve in China.Applicable to more than 95% of mitral valve disease patients (even MAC patients)。

# Clinical Application Cases

January 2022,Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyProfessor Dong Nianguo's team successfully performed a transcatheter mitral valve replacement surgery using the TruDelta® Transcatheter Mitral Valve System for an elderly, high-risk patient with severe mitral regurgitation.First Clinical Implantation in China。

(1) Patient Details

The surgical patient is an elderly woman who has experienced intermittent episodes of palpitations after activity over the years. In the past year, the patient's symptoms of chest tightness and shortness of breath have progressively worsened, leading to breathing difficulties that severely impact daily life. She visited Wuhan Union Hospital on December 21, 2021.Echocardiography showsA large amount of regurgitation signal was observed on the left atrial side of the mitral valve orifice during systole.；Severe Mitral Regurgitation; Left atrial enlargement; Left ventricular systolic function borderline; Arrhythmia.

After in-depth analysis and repeated discussions by the expert team at Wuhan Union Hospital, it was ultimately decidedDecided to use the domestically produced mitral valve system (TruDelta®) for the patientMinimally Invasive Transcatheter Mitral Valve Replacement。

(II) Surgical Procedure

(III) Postoperative Evaluation

Professor Dong Nianguo said, "In recent years, an increasing number of surgical procedures can be performed through interventional methods, which offer the advantages of minimal trauma, quick recovery, and convenient operation."TruDelta® Transcatheter Mitral Valve System Anchoring Route is Safe and Reliable, Innovative design canAvoid Left Ventricular Outflow Tract Obstruction; withRecyclable PerformanceEasy to adjust the implantation position; relying on the apex fixation neither damages the valve leaflets or annulus nor is it prone to displacement.A wider range of patients, easier operation，With excellent clinical promotion prospects", looking forward to this product benefiting more patients."

# AboutTrulive

TruliveFounded in 2019, it isA company focused onProviding High-End Interventional Medical Devices for the Cardiovascular Field, and focuses on diseases with high mortality and disability rates as well as fields where domestically produced treatments are lacking. The company's business coversCardiac Valves, Heart Failure, Peripheral and CoronaryThe Four Major Disease Areas, AreThe only cardiovascular interventional platform enterprise in China specializing in solving blood flow direction problems。

TruliveA one-stop toolbox for cardiovascular treatment, providing solutions for various blood flow issues in cardiovascular diseases, includingValve Management——Treatment of heart valve disease, regulating the correct flow of blood;Dredge——Treatment of intravascular stenosis or embolism to ensure smooth blood flow;Shunt——Intervention for heart failure, relieving pathological hypertension.