TruGamma® Transcatheter Tricuspid Valve Replacement System Offers Minimally Invasive Lifeline for Severe Tricuspid Regurgitation

Oct 16, 2024 08:03 CST Updated 08:03

Trulive

Structural Heart Disease Device Developer

Recently, TruGamma® Transcatheter Tricuspid Valve Replacement System, independently developed by Trulive, successfully completed a transcatheter tricuspid valve replacement for a patient with severe tricuspid regurgitation. This surgery was accomplished through multidisciplinary collaboration by a team of structural heart disease experts. The TruGamma® system represents another excellent example of physician-engineering collaboration, driven by innovation and exploration among enterprises, engineers, and doctors. It opens up new horizons in China’s field of interventional treatment for heart valves and will further expand treatment options for patients with valvular diseases globally.

Preoperatively, the expert team conducted a comprehensive assessment of the patient. Given the patient's advanced age and multiple comorbidities, the surgical risk was considered high. After multiple detailed discussions with the patient and their family, the team ultimately decided to use the TruGamma® Transcatheter Tricuspid Valve Replacement System to perform the tricuspid valve replacement, allowing the patient to receive the most effective treatment with minimal risk.

Patient Information

This case involves a 76-year-old male patient with severe tricuspid regurgitation who experienced syncope in June 2023 without obvious cause and was rushed to the local hospital via emergency services. Examination indicated "moderate to severe tricuspid regurgitation," but no specific treatment was administered at the time. In May 2024, due to worsening of his condition, he sought medical attention again. The preliminary diagnosis was valvular heart disease, severe tricuspid insufficiency, persistent atrial fibrillation, grade 3 hypertension (very high risk), hyperlipidemia, history of lung malignancy, and cardiac function class III (NYHA classification). The patient was admitted for further surgical treatment.

Echocardiography suggests: Bilateral atrial enlargement, severe tricuspid regurgitation

Preoperative ultrasound indicated severe tricuspid regurgitation.

Angle Between the Superior Vena Cava and the Tricuspid Annular Axis

Tricuspid Annulus Measurement Values

Surgical Procedure

During the procedure, the operator delivered the tricuspid valve system into the right atrium via the jugular vein along the guidewire under the guidance of transesophageal echocardiography and DSA. The handle was manipulated to steer the device across the valve and adjust its coaxiality and depth to the appropriate position. After confirming the correct position, the release of the clasp to capture the leaflets began, and the valve implantation was successfully completed. Immediate postoperative ultrasound confirmed good coaxiality of the tricuspid valve, firm fixation of the stent, no regurgitation, and no paravalvular leakage. The surgery ended successfully.

Adjust Instrument Depth

Start releasing the ear grip

Release and capture the leaflets with grasping ears

Full Release of the Valve

Good valve function immediately after surgery, no paravalvular leakage

Normal position and function of the pre-discharge ultrasound artificial tricuspid valve, no perivalvular leakage

Postoperatively, the expert team highly praised the application experience and intraoperative performance of TruGamma®. Due to the more complex anatomical structure of the tricuspid valve, the development of interventional devices faces extremely high challenges. Currently, there is still a global gap in related tricuspid valve interventional replacement products. The successful entry of the TruGamma® system into clinical practice is expected to fill this void, allowing more patients with tricuspid regurgitation to extend their lives.

-End-

Product Introduction

TruGamma® Transcatheter Tricuspid Valve Replacement System Clinical Trial Collaborates with Multiple Renowned Cardiac Centers Across China. The Product Features an Innovative Dual-Layer, Dual-Anchoring Design. Its Stent is Made from Special Materials, and the Animal-Derived Materials Undergo Exclusive Biological Tissue Processing Technology, Offering Significant Advantages in Stability, Tolerance, and Resistance to Calcification. Currently, the Product is Undergoing Clinical Trials in Hospitals That Have Received Ethical Approval. Simultaneously, Efforts Are Being Made to Expand the Product's Reach Internationally, Bringing Hope to Patients Worldwide Suffering from Valve Diseases.

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