NuMed Medical Completes Asia's First Transcatheter Mitral Valve Replacement with Mi-thos System

Recently, the Mi-thos transcatheter mitral valve replacement (TMVR) system, developed by NewMed, a company based in the Shanghai International Medical Zone, was used to perform its first procedure at Zhongshan Hospital Affiliated to Fudan University. This procedure marks the first TMVR case in Asia and signifies that China has joined the forefront of global TMVR research.

It is reported that the 72-year-old patient had been suffering from recurrent chest tightness and shortness of breath upon exertion, paroxysmal nocturnal dyspnea, severe edema of both lower extremities, atrial fibrillation, and frequent premature ventricular contractions for three years. Despite seeking medical attention from multiple sources, no effective treatment was achieved. Given the patient’s advanced age (over 70 years), frail constitution, and poor cardiac function, he was considered at high risk for traditional open-heart surgery. After thorough evaluation and discussion by the heart team at Zhongshan Hospital, it was ultimately decided to perform transcatheter mitral valve replacement (TMVR) on this patient.

During the procedure, the surgeon made only a small incision of approximately 4 cm in the patient’s left chest and advanced a slender catheter through the apex of the heart to the diseased mitral valve site. Mitral valve replacement was rapidly performed while the heart continued to beat, with the key operative steps completed in just 10 minutes. Mitral regurgitation was immediately reduced from severe preoperatively to mild postoperatively. There was virtually no intraoperative bleeding, no conduction block, and no outflow tract obstruction; both blood pressure and heart rate remained stable throughout the procedure.

Mitral regurgitation, the most common valvular heart disease in the elderly, has a prevalence of up to 2% in the general population, with incidence rising steadily with age and exceeding 5% among individuals over 70 years old. Previously, moderate-to-severe mitral regurgitation could only be treated through traditional open-heart surgery requiring cardiopulmonary bypass. However, for elderly high-risk patients with multiple comorbidities, such procedures entail substantial trauma and risk, leading many to forgo surgery and ultimately succumb to untreatable heart failure. Transcatheter Mitral Valve Replacement (TMVR), which avoids thoracotomy, cardiac arrest, and cardiopulmonary bypass, significantly reduces surgical trauma and has emerged as a major research focus following the success of Transcatheter Aortic Valve Replacement (TAVR). In recent years, multiple multidisciplinary teams in Europe and the United States have invested heavily in developing TMVR technologies. Nevertheless, due to the anatomical complexity of the mitral valve, development challenges remain formidable, and all current efforts are still in the exploratory phase, with fewer than 300 successful clinical cases reported worldwide.

PreviouslyMedValleyIn an exclusive interview with NewMed Valley, Yu Qifeng, Chairman of NewMed Medical, also stated that the mitral valve annulus is difficult to stabilize due to its complex morphology, which predisposes patients to paravalvular leakage and may obstruct the outflow tract between the left ventricle and the aorta. For many years, international efforts in this field have remained in a phase of iterative design improvements.

However, as the technology continues to mature, minimally invasive mitral valve replacement and repair devices, as a revolutionary treatment modality, are increasingly gaining recognition among experts. In the foreseeable future, clinical demand is expected to experience explosive growth.

The Mi-thos transcatheter mitral valve replacement system, developed by NewMed, significantly simplifies the mitral valve replacement procedure, substantially reduces treatment risks, and markedly improves success rates. It also lowers surgical costs for patients and shortens postoperative recovery time. “Through a minimally invasive apical small incision, the device is delivered via catheter to the mitral valve region, where it automatically expands. While open-heart surgery typically takes four to five hours, our procedure requires only one to two hours,” Yu Qifeng, CEO of NewMed, stated in an interview with Yigu.

High-quality products rely on a robust R&D talent pool. It is reported that NewMed’s core team members all possess over 15 years of industry experience and have established project-based collaborations with multiple universities and Grade A tertiary hospitals, including Zhongshan Hospital, Xijing Hospital, Fuwai Hospital, Sichuan University, Zhejiang University, and Tsinghua University. In terms of raw materials and product manufacturing, the company adheres closely to international standards, partnering exclusively with suppliers that maintain long-term cooperative relationships with renowned companies such as Medtronic and Edwards Lifesciences.

As of now, NewMed has filed for more than 50 patents and was awarded the National "13th Five-Year Plan" Key R&D Program and the Shanghai "Science and Technology Innovation Action Plan" in 2016.PharmaceuticalsSupported by key scientific and technological projects in the field, the company secured third place in the corporate category of the biomedical industry at the 5th China Innovation and Entrepreneurship Competition. Last April, it also completed a Series A financing round amounting to tens of millions of RMB, led by Lize Capital and participated in by Taihao Venture Capital.