Luoyi Medical's Novel Vascular Closure Device Gains NMPA Approval, Accelerating Domestic Substitution in China

The Field of Vascular Closure Is Witnessing New Product Breakthroughs.

In late February, Luoyi Medical’s independently developed VI001-1 Vascular Suture System officially obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA).Its approval also signifies the emergence of a new competitor in the field of vascular closure, further advancing the domestic substitution of imported vascular suture technologies in China. This will help reduce the risk of puncture-related complications, improve intraoperative product accessibility for patients, and alleviate their financial burden, ultimately benefiting a broad patient population.

Source: Official Website of the National Medical Products Administration

Driven by clinical advantages such as minimal invasiveness and rapid recovery, interventional therapy is experiencing rapid development. The swift growth in the volume of interventional procedures has further fueled expansion in the related medical device market. According to Frost & Sullivan, the market size of cardiovascular interventional devices in China reached RMB 37.2 billion in 2021 and is projected to reach RMB 140.2 billion by 2030, representing a compound annual growth rate (CAGR) of approximately 15.9%.

With the rapid development of interventional therapy, the clinical demand for vascular access site closure is also growing rapidly. Sun Ningtao, General Manager of Luoyi Medical, pointed out, “There are two major approaches for vascular intervention: one is the femoral artery, and the other is the radial artery. Taking the femoral artery approach as an example, hemostasis methods include mechanical compression, manual compression, and closure devices.”

Sun Ningtao, General Manager of Luoyi Medical

Traditional compression hemostasis is time-consuming, difficult to manage in nursing care, and carries a high risk of vascular complications (including hematoma, pseudoaneurysm, arteriovenous fistula, etc.), which seriously affects patients' postoperative recovery and the turnover efficiency of medical resources. Considering that existing coagulation-promoting and staple/clip-type vascular closure devices on the market have limited effectiveness in closing large-bore vascular wounds,Luoyi Medical has chosen to enter the market with closure devices, focusing on large-bore vascular closure. It has developed suture-based vascular closure devices—a product category with high technical barriers and limited presence among domestic manufacturers in China.

As a product designed for rapid, accurate, and effective suturing of vascular incisions or puncture sites during surgery, vascular suturing devices are widely used in vascular surgical and interventional procedures, such as angioplasty, bypass surgery, aneurysm resection, and closure after vascular puncture. These devices can effectively simplify and accelerate the process of vascular closure, further reducing patients' operative time, enhancing surgical safety and success rates, and lowering the risk of postoperative complications.

According to Frost & Sullivan data, the number of vascular closure procedures in China increased from 107,500 in 2015 to 274,300 in 2019, and is projected to further rise to 3.7821 million by 2030. This undoubtedly represents a market with immense potential.

However, in the past, this field was long dominated by foreign companies such as Abbott. With Chinese manufacturers obtaining regulatory approvals and launching subsequent products, Sun Ningtao pointed out that,“Around 2026 may usher in the first year of replacement for vascular closure device products.”

This is closely linked to innovation in domestically produced vascular closure devices.

LuoYi Medical’s independently developed vascular suturing device consists of two components: a suture applicator and a suture adjuster. It achieves immediate closure of the vascular puncture site using pre-tied knots through a four-step process: positioning, needle insertion, needle withdrawal, and knot locking. The device is compatible with puncture sizes ranging from 5F to 21F, effectively covering access sites for all transfemoral arterial interventions, and addresses the challenge of closing large-bore puncture sites through its precise intracorporeal suturing mechanism.

It is worth noting that,Luoyi Medical's vascular closure device underwent clinical trials at leading Chinese medical institutions, including Peking University People's Hospital, Peking University First Hospital, and Xuanwu Hospital of Capital Medical University.The aforementioned hospitals hold a pivotal position in the field of cardiovascular medicine. Xuanwu Hospital, for instance, hosts the National Center for Neurological Disorders, the China International Neuroscience Institute, and the National Clinical Research Center for Geriatric Diseases. It ranks among the leading institutions in China in terms of comprehensive strength and boasts a neuroscience cluster that has attracted significant attention both domestically and internationally. Currently, multi-center clinical trials have demonstrated that Luoyi Medical’s vascular closure devices exhibit excellent performance in core metrics, including safety, efficacy, and human-machine interaction.

The acceptance and recognition by leading hospitals reflect not only an endorsement of domestic innovation but also a strong affirmation of Luoyi Medical’s products. It is reported that Luoyi Medical once removed product branding to allow physicians to evaluate the devices based solely on their clinical experience. The physicians gave high ratings to the products in terms of operational smoothness, comfort, and human–machine interaction.

To better address issues such as puncture failure encountered by existing vascular closure devices in patients with vascular calcification, Luoyi Medical has introduced innovations to enhance the puncture capability of the device’s needle and further improve suturing success rates by optimizing details such as the distance between the anterior and posterior needles.

In fact, since Abbott’s vascular closure device entered the Chinese market in 2009, domestically produced alternatives did not emerge until 2024. To date, only three domestically manufactured vascular closure devices have received regulatory approval, one of which is Luoyi Medical’s vascular closure device. This underscores the significant technical challenges involved.

Sun Ningtao introduced, “Since Abbott’s vascular closure device was introduced to the Chinese market in 2009, a large number of companies have been engaged in the research and development of related products. However, most manufacturers underestimated the difficulty of developing vascular closure devices. A vascular closure device comprises more than 50 components, which must be correctly configured to work in concert. Moreover, the relevant components demand extremely high machining precision; at that timeThe manufacturing capabilities of existing equipment fail to meet the requirements for related products, and the process complexity is even far greater than that of balloons and stents, ultimately leading many manufacturers to abandon the research and development of such products.Furthermore, addressing quality control issues in the manufacturing of vascular closure devices presents a significant challenge. Given that comparable time and effort could be allocated to other projects with better cost-effectiveness, many teams have opted to shift their focus to different fields.

In summary, under the combined influence of multiple factors, domestic manufacturers only obtained the relevant registration certificates more than a decade after imported products entered the Chinese market. Luoyi Medical’s successful acquisition of NMPA registration is also attributable to its team.Luoyi Medical was co-founded by its founders together with senior clinical experts in the field of vascular medicine.Its general manager has prior experience working at leading overseas medical device companies such as Abbott and Medtronic, and is well-versed in the R&D, production, and sales processes for innovative medical devices. The company’s CTO brings extensive project R&D experience with high-end medical device consumables, including mechanical heart valves and coronary stents, demonstrating comprehensive mastery of R&D, production, and manufacturing processes. Thanks to the collaborative support of the team and medical experts, Luoyi Medical began incubating this project in 2019, completed prototype development and established its presence in Beijing in 2021, and officially obtained NMPA registration approval in 2025.

Following certification, Luoyi Medical is further intensifying its efforts in product launch and subsequent market promotion.

From a production perspective, Luoyi Medical has established a modern manufacturing base in the Beijing Economic-Technological Development Area, equipped with Class 10,000 cleanrooms and specialized testing areas. With a professional quality control team and comprehensive testing equipment, the company has formed a full-process quality control system spanning from research and development to production.It is reported that its production workshop has an annual capacity of 100,000 vascular suturing devices. By innovatively applying new composite materials and precision manufacturing processes, and achieving independent design and production across the entire component lifecycle, Luoyi Medical ensures product quality stability and controllable production costs at the source. Leveraging the advantages of a localized supply chain, the company has established an efficient and collaborative material assurance system, with a localization rate of 96%.

From a marketing perspective, Luoyi Medical is adopting a dual-pronged strategy. On one hand, Luoyi Medical is accelerating its collaborations with third-party distributors.Sun Ningtao stated, “In the two weeks since our product received market approval and was launched, over a hundred distributors have contacted us, expressing interest in becoming our authorized agents. We are currently screening potential distribution partners.”On the other hand, Luoyi Medical is also considering joining local centralized procurement programs.“Volume-based procurement is beneficial for startups; in the absence of mature distribution channels established by large corporations, it can help companies rapidly expand their market presence.”

In the process of domestic substitution, Luoyi Medical has long recognized the potential challenges it may face, namely information asymmetry with physicians and product pricing issues. Nevertheless, Luoyi Medical is confident in its competitive advantages in product quality and cost efficiency. The company is focusing on the future market, anticipating that the vascular closure sector will experience rapid growth driven by China’s deepening aging population, the swift increase in interventional procedures, and further supportive national policies.

To better meet clinical needs,Luoyi Medical is also further expanding its product R&D pipeline, with a continued focus on the field of vascular intervention and vascular closure., to address the current challenges in suturing large-diameter blood vessels. Subsequently, it will further launch products capable of suturing 21F vessels with a single device, as well as 5F and 6F puncture closure devices for neurointerventional and oncological interventional procedures. In the field of congenital heart disease, Luoyi Medical will also develop suture-based products to overcome the foreign body issues associated with the current use of occluders. The research and development of multiple innovative products are already part of Luoyi Medical’s development roadmap.

For Luoyi Medical, the company will focus on the field of vascular closure, striving to become a leader in closure products within China’s vascular intervention sector. By further developing its flagship products, Luoyi Medical aims to provide clinicians with superior and more reliable vascular closure solutions, ultimately benefiting patients.

andAt the upcoming “China Medical Equipment Conference and 2025 Medical Equipment Exhibition” (March 13–16), Luoyi Medical will also showcase its innovative products.Industry professionals interested in Luoyi Medical are welcome to visit Booth N1B02 at the Chongqing International Expo Center for communication and exchange.