Zhenyi Medical's PV-Linc® Peripheral Covered Stent System Granted NMPA Innovative Medical Device Designation

Mar 07, 2025 18:00 CST Updated 18:00

Trulive

Structural Heart Disease Device Developer

Following the conclusion of the public announcement for the special review application of innovative medical devices (No. 2, 2025), PV-Linc®, the peripherally coated stent system independently developed by Trulive, has officially been approved by the special review application for innovative medical devices from the National Medical Products Administration (NMPA) of China. The product's approval marks another innovative product of Trulive entering a rapid development phase, demonstrating the high recognition from Chinese regulatory authorities of the product’s technological breakthroughs and clinical value. This will accelerate the product’s market access process, benefiting more patients with peripheral artery disease.

Source | NMPA

The prevalence of Peripheral Artery Disease (PAD) exceeds 4% in adults aged 40 and above. PAD increases sharply with age, with a prevalence of over 14% in people aged 70 or older. Conservative estimates suggest that more than 200 million people worldwide suffer from PAD, with the incidence rate increasing by 23.5% in just the first decade of this century. Stent graft implantation is a method of peripheral vascular interventional treatment used to open blocked arteries and restore normal blood flow, thereby alleviating patient symptoms and preventing complications.PADHigh-speed incidenceClimbing, especially among the elderly population,This has driven an urgent demand for covered stents in this application field.

PV-Linc® is a leading peripheral artery balloon-expandable covered stent produced in China. Compared with traditional bare stents, the product combines the features of a covered design, balloon-expandable deployment, and post-dilation capability. Based on current research into the treatment of aortoiliac artery stenosis or occlusive lesions, the product demonstrates significant advantages in treating thrombotic lesions, preventing arterial rupture, and avoiding in-stent restenosis.On a large clinical scale,PV-Linc® Stent Graft ClinicalThe results also demonstrated good safety and effectiveness, receiving high praise from many clinicians and patients.

This time, PV-Linc® entering the NMPA innovative review green channel will not only provide a new treatment option for patients with peripheral artery disease in China but also promote technological innovation in the field of peripheral vascular disease treatment. Next, Trulive will collaborate with top hospitals and expert teams in China to actively advance the product's clinical research and market layout globally, continuously pushing forward the implementation of the PV-Linc® project, allowing patients to benefit more quickly from innovative technology.

Trulive

Jiangsu Trulive Medtech Co., Ltd. focuses on the field of cardiovascular diseases, which have extremely high mortality and disability rates and where the domestic market remains a gap. Its business comprehensively covers multiple interventional treatment areas such as heart valves, peripheral, and coronary arteries. It is a platform enterprise that has taken the lead in providing a one-stop innovative solution for blood flow management globally. With strong research and development capabilities and an experienced, complete operational team, Trulive Medtech has developed high-quality domestically produced medical devices with independent intellectual property rights and comprehensive solutions starting from the product itself. This fills the gap in China’s high-end cardiovascular interventional medical devices, offering more advanced and diverse treatment options to Chinese doctors and patients. Meanwhile, Trulive Medtech, based in China and strategically expanding worldwide, continues to upgrade through technological innovation and development. The company accelerates the expansion of its global commercial network, providing "Chinese solutions" and contributing "Chinese wisdom" in many细分 markets within the cardiovascular intervention field that have long been monopolized by imported products.

Scan the QR code to follow us

Business Cooperation | 021-50625001-8930

Email Address | vicky.z@trulive.cn

Source | Trulive Medtech