Successful Clinical Application of China's First Transcatheter Mitral Valve Repair Device, MitralStitch™

Thursday, February 1, 2018 Clinical Trials News
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HANGZHOU, China, Feb. 1, 2018 /PRNewswire/ -- On January 19, 2018, the global first clinical

case of MitralStitch mitral valve repair system was completed at Yunnan Fuwai Hospital, China. This operation was jointly
performed by the team of Professor Pan Xiangbin and Professor Meng Xu from Beijing Anzhen Hospital under the guidance of Academician Hu Shengshou from Fuwai Hospital. The operation used the MitralStitch mitral valve repair system, which is independently developed by Hangzhou DeJin Medtech Co., Ltd., an affiliate company of DiNovA Medtech. This is the first clinical application of minimally invasive transcatheter mitral valve therapies device that can be simultaneously performed in edge-to-edge repair procedure and chordal repair procedure.

According to statistics, in the United States, there are 4.6 million patients with mitral regurgitation. The transcatheter interventional mitral valve technology will bring benefits to patients who cannot be treated surgically, especially those with moderate-to-severe mitral regurgitation and those with high-risk contraindication in surgery.

Currently, various mitral valve related devices have been developed around the world, but only a very limited number of them are already on the market and certified by the European CE and the US Food and Drug Administration (FDA), among which MitraClip holds the biggest market share. MitralStitch™, developed by a team consisted of experts from Dejin Medtech, Bejing Fuwai Hospital and Beijing Anzhen Hospital, is the first device in the world that can repair both the degenerative mitral regurgitation (DMR) and the functional mitral regurgitation (FMR).

During the operation, the elderly patient who received the treatment was diagnosed as mitral valve prolapse with severe mitral regurgitation and medium tricuspid regurgitation. A small incision width 3-4cm was made between ribs of patient, and MitralStitch mitral valve repair system accessed the left ventricle through the apex of heart. Under the guidance of transesophageal ultrasound, apparatus forceps was operated to clamp prolapsed posterior leaflet of mitral valve and implant artificial chordae tendineae. The operation lasted for 25 minutes, from the introduction of MitralStitch to the implantation of artificial chordae tendineae. The degree of mitral valve regurgitation reduced to mild after operation, and the reflux area decreased from 11.3 cm2 to 1.3 cm2. The ultrasound reexamination before discharge showed that the degree of regurgitation decreased to a very small amount and the patient's mitral valve function was normal. The patient's symptoms were improved significantly.

In the first half year of 2018, MitralStitch will conduct an international multi-center clinical trial led by Academician Hu Shengshou which will provide more patients with safe and reliable mitral valve repair devices. At the same time, the second generation of mitral valve repair device and the first generation of tricuspid repair device of DeJin Medtech have also entered the animals experiment stage and are expected to enter the human clinical trial soon.

About DeJin Medtech

Headquartered in Hangzhou, China, Hangzhou DeJin Medtech Co., Ltd. is an innovative medical apparatus and instrument R&D enterprise engaged in the repair treatment of mitral and tricuspid valve. The company was incubated by DiNovA Medtech Group.

About DiNovA Medtech

Headquartered in Hangzhou, China, DiNovA Medtech is a hatching institution specialized in the research and development of subversive medical device technology. It currently focuses on the research and development of heart and lung disease-related technology. DiNovA has successfully incubated Venus MedTech Inc., which focuses on the catheter heart valve replacement, Nuomao Medtech, which focuses on the atrial fibrillation, and Weiqiang Medtech, which focuses on the peripheral vascular disease, among others, and ceaselessly makes overall arrangement in the field of structural heart disease and heart failure. DiNovA Medtech is expected to launch disruptive medical device technology for the treatment of various cardiomyopathy and end-stage heart failure this year.

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SOURCE Hangzhou DeJin Medtech Co., Ltd.

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