First-in-Human Procedure Performed With Hangzhou Valgen’s DragonFly-T Device

December 21, 2020—Hangzhou Valgen Medtech Co., Ltd. announced that Professor Wang Jian’an’s team from the Second Hospital of Zhejiang University School of Medicine in Hangzhou, Zhejiang Province, People’s Republic of China, successfully used the DragonFly-T transcatheter tricuspid valve clamping system to perform the first human clinical application in mainland China.

As explained in the company’s announcement, the patient was a woman, age 79 years, with recurrent chest tightness for more than 1 year and was diagnosed with atrial fibrillation, functional tricuspid regurgitation, class IV cardiac function, and ascites. Preoperative transthoracic echocardiography revealed extremely severe tricuspid regurgitation, bilateral atrial enlargement, tricuspid regurgitant width of approximately 0.84 cm, effective tricuspid regurgitant orifice area of 0.84 cm², and pulmonary artery systolic pressure of 39 mm Hg.

The company noted that although the patient had undergone adequate and optimal medication, she still had recurrent heart failure episodes, the risk of open-heart surgery was extremely high, and she could not be effectively treated in several hospitals.

Prof. Wang’s team decided to perform a minimally invasive tricuspid valve repair via the femoral vein route using the DragonFly-T device.

The operation was performed under general anesthesia with a femoral vein approach. The clip was delivered to the right ventricle under transesophageal echocardiography and x-ray guidance to capture and clamp the anterior and septum tricuspid valve leaflets, and close the valve clip. A total of three valve clips were implanted, and the clips were in good position and function. The tricuspid regurgitation grade decreased from 5+ preoperatively to 1+ immediately postoperatively, and the hepatic venous flow improved significantly. The operation was completed successfully.

The patient was able to move around on her own the day after the operation, and her existing discomfort was significantly reduced. She was discharged from the hospital 2 days after the operation, and a transthoracic ultrasound examination before discharge showed mild tricuspid regurgitation with a regurgitation grade of 1+.

In Hangzhou Valgen Medtech’s announcement, Prof. Wang commented, “The population of tricuspid regurgitation patients in China is wide and often with many comorbidities, the current clinical medication treatment is less effective, and the surgical treatment of tricuspid regurgitation [remains high risk], and the recommendation of tricuspid regurgitation in clinical guidelines [is still absent]. In this patient, we achieved a very promising result with the DragonFly-T device and look forward to further studies to demonstrate the effectiveness and safety of DragonFly-T.”