Leisheng Medical Secures NMPA Class III Approval for Endovenous Closure System, Expands Beyond Varicose Veins

Minimally Invasive Treatment for Varicose Veins Welcomes a New Breakthrough Tool.

Recently,Kunshan Leisheng Medical Technology Co., Ltd. (hereinafter referred to as "Leisheng Medical") has officially obtained approval for the Class III medical device registration certificate from the National Medical Products Administration (NMPA) for its independently developed endovenous closure system.It is reported that the system mainly comprises two types of products: a radiofrequency (RF) generator for venous ablation and disposable endovenous RF closure catheters. By leveraging thermal effects to occlude diseased veins, the system achieves the treatment of varicose veins. Previously, the related products had all obtained CE certification in the European Union.

“Leisheng Medical’s independently developed endovenous closure system achieves international leading standards across multiple functional and performance indicators, including procedural control, safety performance, control precision, and the accuracy of impedance and temperature sensing,” stated Dr. Tan Wei, General Manager and Head of R&D at Leisheng Medical.

Since its establishment in 2017, Leisheng Medical has been dedicated to the research, development, and manufacturing of high-end, niche active minimally invasive surgical products. The recent approval of its endovenous closure system further enriches the company’s portfolio of active medical devices, accelerates the domestic substitution of related medical devices, and promotes the advancement of minimally invasive treatments for varicose veins in China.

Driven by unhealthy lifestyle habits and population aging, the number of patients with varicose veins in China is gradually increasing, resulting in substantial clinical treatment demand. In 2019, the number of individuals affected by varicose veins in China reached 399.4 million, and this figure is projected to rise to 476.6 million by 2030, with a notable trend toward younger onset.

Because varicose veins often present with no obvious symptoms in the early stages—aside from visible bulging vessels that affect cosmetic appearance—they do not substantially impact patients’ daily lives, leading many to forgo medical consultation. In reality, however, varicose veins result from damage to the internal structure of blood vessels; the venous valves have sustained organic impairment that is irreversible. Without treatment, the condition will not improve but will instead continue to worsen.

Currently, the clinical field often classifies the progression of varicose veins in patients into six stages, from C1 to C6. In the later stages of the condition,Varicose veins are no longer merely a cosmetic nuisance; they can lead to ulcers, thrombus formation, and even life-threatening pulmonary embolism.With the advancement of vascular surgery as a discipline and rising consumer spending power, an increasing number of patients with varicose veins are opting for early surgical intervention. Leisheng Medical aims to provide more convenient solutions for such surgical treatments.

According to reports, Leisheng Medical’s venous radiofrequency ablation system, which has just obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA), treats varicose veins by closing diseased vessels through thermal effects.

Currently, over 80% of hospitals in China still perform traditional great saphenous vein stripping, a procedure characterized by prolonged operative time, significant trauma, and slow postoperative recovery. In contrast to traditional great saphenous vein stripping, the endovenous radiofrequency ablation (RFA) closure technique, which Leisheng Medical specializes in, is simple, rapid, minimally invasive, associated with less patient pain, and has fewer complications. Compared with emerging therapies such as laser ablation, sclerotherapy, mechanochemical ablation (MOCA), and cyanoacrylate glue closure, endovenous closure demonstrates certain advantages in terms of vessel occlusion rate, stability, and complication incidence.

In fact, radiofrequency ablation closure has been widely adopted in Europe and the United States for over a decade, with its clinical efficacy extensively validated. The Clinical Practice Guidelines of the Society for Vascular Surgery in the United States recommend ablation as the first-line treatment for the main trunk of varicose veins. However, this technique has not yet gained widespread adoption in China, where domestically produced products and medical insurance reimbursement policies have yet to keep pace.

Dr. Tan Wei predicted that,Over the next five years, radiofrequency-based endovenous ablation systems will present significant opportunities for adoption in China and along the Belt and Road Initiative countries, rapidly replacing traditional great saphenous vein surgery.

Although radiofrequency ablation closure offers a series of advantages over traditional techniques, certain limitations remain in clinical practice.

As mentioned above, radiofrequency ablation closure works by using thermal effects to close diseased blood vessels. However, since the human great saphenous vein is very thin, insufficient radiofrequency energy may prevent adequate vessel contraction; conversely, excessive thermal energy can cause damage to the diseased vessel and surrounding tissues and nerves.

This also makes endovenous ablation highly dependent on physicians’ experience and technical proficiency. In particular, grassroots physicians often struggle to master the nuances of energy delivery, yet a large proportion of patients with varicose veins in China seek care at primary-level hospitals. Furthermore, worldwide, patients in developed countries typically present for treatment at earlier stages of the disease, whereas most Chinese patients are already in the middle or late stages when they opt for therapy. These factors further complicate and challenge the real-world management of varicose veins in China.

To address this clinical pain point, Leisheng Medical’s endovenous closure system has improved its control algorithms, enabling intelligent control during the endovenous closure procedure.

During endovenous closure, variables such as temperature, impedance around the ablation catheter, and voltage all influence the final therapeutic outcome. Leisheng Medical’s radiofrequency generator for venous ablation can infer the treatment status of diseased vessels through multi-variable signal feedback, thereby controlling energy output to optimize therapeutic efficacy.

In fact, China’s active medical device sector has long been monopolized by imported giants, with the design of energy generators representing a particular technical challenge; few domestic companies have mastered the relevant technologies.

While optimizing therapeutic efficacy, the more intelligent control has also significantly reduced the clinical operational difficulty of Rayshen Medical’s endovenous closure system.Doctors can get started quickly, with a shorter learning curve, better meet the treatment needs of complex cases, and support the development of China's primary healthcare system.

In March 2021, Leisheng Medical’s endovenous closure products completed randomized controlled clinical trials at four research centers in China. Clinical data demonstrated that, leveraging Leisheng Medical’s proprietary control algorithms and patented technologies,Its endovenous closure system achieved a 100% occlusion rate and fewer complications in patients with great saphenous vein varicosities at all stages., demonstrating favorable clinical trial results.

Following the approval of its core product, Leisheng Medical’s functions are also undergoing a transformation.

“The journey from R&D to regulatory approval, and then to mass production and sales, is not an overnight process. Lei Sheng Medical will next focus on production and quality management, optimize its production lines, and seek collaborations with external sales teams. The market we face is vast; once our products obtain registration certificates, the company must rapidly scale up production while ensuring quality,” said Tan Wei.

According to reports, Leisheng Medical has established a 1,600-square-meter integrated R&D and production base. This facility includes a production area for endovenous radiofrequency ablation catheters and a Class 10,000 cleanroom workshop spanning over 600 square meters, a production workshop for venous ablation radiofrequency generators covering more than 700 square meters, and an R&D space of over 250 square meters. The base has an annual production capacity of 40,000 catheters and 1,000 generators.

However, the registration and commercial launch of the endovenous closure system do not signify the endpoint of Leisheng Medical’s R&D efforts.

As an R&D-focused company, the Leisheng Medical team has accumulated extensive experience in the medical device sector. Dr. Tan Wei, the company’s General Manager and head of R&D, holds a Master’s degree in Electrical Engineering and a Ph.D. in Biomedical Engineering from the University of Southern California. Prior to leading Leisheng, he engaged in the research and development of advanced diagnostic and therapeutic technologies at several medical device companies and research institutions in both China and the United States. The company boasts an elite, multidisciplinary team comprising experts in R&D, operations, management, and clinical affairs.

Since its inception, Leisheng Medical has been dedicated to the development of active surgical instruments. The company’s objective is to establish an active platform that leverages underlying radiofrequency (RF) control technologies and intelligent control algorithms to accommodate diverse clinical scenarios, such as tumor intervention and thyroid RF ablation. This approach allows the company to address varying clinical needs simply by adjusting control programs and developing disposable consumables.

Through a platform-based design, an active surgical system can be applied to multiple specialized fields such as venous intervention, arterial intervention, and tumor intervention, meeting the needs of various departments. This not only significantly improves surgical efficiency and quality but also reduces hospital procurement costs.

Currently, Leisheng Medical has resolved underlying technical issues to ensure precise and safe system control. The company emphasizes a development pathway that integrates medicine and engineering, collaborating with multiple Grade A tertiary hospitals in China to accumulate clinical data. During disease treatment, it precisely controls parameters such as therapeutic temperature, product power, and electrical impedance, while continuously optimizing algorithms to achieve optimal therapeutic outcomes. Consequently, all of the company’s products are developed based on clinical insights to address actual clinical needs.

“Only through temporal validation and market screening can original technologies and products achieve a leading position. Amidst the changing macro environment, Leisheng Medical will continue to leverage its core strengths on the active platform to develop more actively powered medical devices with original significance,” stated Tan Wei.