Zhenyi Medical's Innovative PV-Linc® Peripheral Covered Stent System Granted NMPA Innovative Medical Device Designation
Trulive
Structural Heart Disease Device Developer
Following the conclusion of the announcement on the review results of the Special Review Application for Innovative Medical Devices (No. 2, 2025), PV-Linc®, the peripheral artery covered stent system independently developed by Trulive, has officially been approved through the Special Review Application for Innovative Medical Devices by the National Medical Products Administration (NMPA) of China. The product's approval marks another innovative product from Trulive entering a rapid development phase, demonstrating the high recognition by 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.
The prevalence of Peripheral Artery Disease (PAD) exceeds 4% in adults aged 40 years and older. The incidence of PAD increases sharply with age, with a prevalence of over 14% in individuals aged 70 years or older. Conservative estimates indicate that more than 200 million people worldwide are affected by PAD, with a 23.5% increase in incidence during the first decade of this century alone. Stent graft implantation is one method of peripheral vascular interventional treatment, used to open blocked arteries and restore normal blood flow, thereby alleviating symptoms and preventing complications in patients.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 arterial balloon-expandable covered stent produced in China. Compared with traditional bare stents, the product features 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 so that patients can benefit more quickly from this innovative technology.
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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 blank slate. Its business comprehensively covers multiple interventional treatment areas such as heart valves, peripherals, and coronary arteries. It is a platform enterprise that takes the lead in providing one-stop innovative solutions for blood flow management on a global scale. 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, filling the gap in China’s high-end cardiovascular interventional medical device market. This provides Chinese doctors and patients with more advanced and diverse treatment options. Meanwhile, Trulive Medtech, rooted in China while strategically expanding globally, continuously upgrades through technological innovation and development. The company accelerates the expansion of its global commercial network, offering "Chinese solutions" and contributing "Chinese wisdom" to various niche markets in the cardiovascular intervention field that have long been monopolized by imported products.
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Email Address | vicky.z@trulive.cn