EnSheng Medical's Domestically Developed VeSeal Venous Closure System Completes First-in-China Clinical Enrollment, Offering Innovative Solution for Over 100 Million Varicose Vein Patients

Recently,ShanghaiEnsheng MedicalTechnology Co., Ltd.Developed for the treatment of varicose veinsVeSealVenous Closure System at Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of MedicineCompleted the first clinical application in China, and it is also its second intravenous product for clinical use.

The procedure was performed by the team led by Director Lu Xinwu of the Department of Vascular Surgery at Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine. The successful implementation of this surgery marks a breakthrough for domestic innovative enterprises in the field of varicose veins and signifies a new treatment option for varicose veins in China.

The patient enrolled in this clinical trial was a 63-year-old male whose varicose veins met the inclusion and exclusion criteria of the study protocol. Following evaluation by the team led by Director Lu Xinwu at Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, the VeSeal Venous Closure System, independently developed by Ensheng Medical, was selected. Under ultrasound guidance, the diseased veins were occluded via a minimally invasive interventional approach, with the entire procedure completed in under half an hour.

According to the introduction, unlike other clinical studies, the VeSeal Venous Closure System is also equipped with standard accessories such as delivery guidewires and catheter sheaths. The injection catheter is visible in real-time under ultrasound, and the sheath features measurement markings. No additional accessories are required during the procedure, enabling clinicians to occlude diseased veins rapidly, conveniently, and efficiently.

As the most advanced global treatment for varicose veins, vena cava closure offers numerous advantages; however, no related products have yet been approved in China. The VeSeal Venous Closure System, developed by Ensheng Medical, fills this domestic gap, enabling outpatient daytime treatment of varicose veins. It features short operative times and high bed turnover rates. Patients do not require tumescent anesthesia injection, thereby eliminating the risk of thermal injury, and can ambulate immediately after the procedure.

Varicose Veins (VV) is a common peripheral vascular disease characterized by dilation, bulging, and tortuosity of the venous walls.

For most people, the technical term "lower extremity varicose veins" may be unfamiliar, but this condition, commonly known as "chronic leg ulcers" or "earthworm legs," is actually quite prevalent. According to the "2021 Internet Health Insight Report on Varicose Veins," there are 120 million patients with lower extremity varicose veins in China, over 80 million of whom are women, and the disease is showing a trend toward affecting younger populations.

Clinical experts state that common symptoms of varicose veins include heaviness in the lower limbs, aching and discomfort, and calf cramps. In severe cases, complications may include thrombosis within the varicose veins, lower limb ulcers, and vessel rupture.

Currently, clinical treatment for varicose veins is primarily categorized into three types: physical therapy, pharmacological therapy, and surgical intervention. Among these, both physical therapy and pharmacological therapy can only delay disease progression and alleviate symptoms.

Surgical treatments, including great saphenous vein stripping, foam sclerotherapy, and energy-based endovenous ablation, can provide a curative solution for varicose veins. However, these surgical approaches still present numerous clinical challenges. For instance, energy-based endovenous ablation carries a risk of injury to adjacent nerves and normal tissues, while great saphenous vein stripping is associated with significant trauma and procedural complexity, making it difficult to implement in primary care settings.

Ensheng Medical stated, “Compared with the aforementioned surgical treatment methods, the newly emerged endoluminal closure technique using cyanoacrylate internationally”“It is faster, causes less patient discomfort, requires no injection of tumescent anesthetic fluid, and can be completed through a single puncture site, making it the most suitable procedure for outpatient settings at present.”

Data shows that endovenous cyanoacrylate closure isBy injecting adhesive glue into the venous lumen, the incompetent venous lumen is completely occluded to eliminate reflux.Permanent treatment of varicose veins can be achieved by occluding superficial veins with venous closure adhesive.

Currently, Medtronic’s VenaSeal Venous Closure System is the only product of its kind approved by the U.S. Food and Drug Administration (FDA) worldwide, leaving the Chinese domestic market still untapped.

In response, Ensheng Medical has pioneered the development of the VeSeal Venous Closure System for the treatment of varicose veins in China. Adopting a non-thermal therapeutic approach, this system offers enhanced safety and convenience compared to endovenous thermal ablation techniques. The procedure features shorter operative times, eliminates the need for tumescent anesthesia, and results in fewer side effects. Patients can resume physical activity immediately after surgery, thereby improving clinical workflow efficiency.

Ensheng Medical's VeSealThe venous closure system has completed its first clinical enrollment and achieved excellent clinical outcomes, indicating that a minimally invasive, safe, rapid, and low-trauma innovative therapy will become available for the treatment of varicose veins in China, thereby providing a superior option for clinical management.

Additionally, female patients with varicose veins may present with the symptom of "prominent blue veins." As a minimally invasive procedure, endovenous cyanoacrylate closure is considered an aesthetic-enhancing treatment for many female patients today.

EnSheng Medical’s independently developed VeSeal Venous Closure System consists of a venous closure agent and delivery accessories, which include a standard 0.035-inch guidewire, a 5F catheter sheath, an injection catheter, and a standard syringe.

In terms of performance, VeSeal offers the following advantages:

1. Develop a complete venous closure system, ensuring precise and convenient surgical procedures.The entire system can effectively prevent surgeons fromSingle-product matching facilitates surgical procedures for physicians and enhances clinical efficiency. The delivery accessories are visible in real time under ultrasound guidance, and the catheter sheath features graduations for intraoperative reference, enabling precise glue injection. Furthermore, the entire system is presented in meticulously designed packaging, custom-tailored to the preferences of Chinese physicians for convenient use and ease of operation.

2. The venous closure agent has higher viscosity and better closure efficiency.VeSeal Venous Closure System: Featuring superior adhesive strength and excellent flexibility, with controllable curing time to achieve optimal venous occlusion and reduce disease recurrence rates.

3. Standardize the device specifications for venous closure agents, with sufficient dosage for bilateral leg treatment, better aligns with clinical needs and reduces surgical costs for patients.

4. Electric syringes replace disposable hand-held pumps, reducing costly surgical expenses.Develop an automated injection system for sclerosing agents, enabling human-machine interactive automatic administration. The procedure can be completed by a single operator, thereby preventing adverse events caused by operator error. By developing a quantitative and timed injection system for sclerosing agents, Ensheng Medical can automate the closure treatment of varicose veins, achieving full machine-driven execution.

5、VeSealSafe, non-toxic, and with good biocompatibility,It can instantly seal blood vessels and occlude veins, leading to gradual muscularization of the vessels over time, thereby achieving a complete cure for varicose veins.

In recent years, the treatment of lower extremity varicose veins has undergone significant changes. Traditional surgical procedures are gradually being replaced by newer approaches, and minimally invasive therapies have gained widespread acceptance. Through clinical research and exploration, endovenous venous glue closure has emerged as the latest mainstream modality for treating lower extremity varicose veins, owing to its advantages of simplicity, rapidity, minimal invasiveness, and reduced tissue trauma.

It is expected that with the market launch of Ensheng Medical’s VeSeal Venous Closure System, it will capture the varicose vein market by virtue of its advantages, including more minimally invasive procedures, enhanced safety, superior clinical efficacy, and fewer complications, thereby filling a domestic gap in China.

Ensheng Medical stated, “We hope that after the VeSeal Venous Closure System is launched, it will generate economic returns while also fulfilling its social responsibility, thereby making a modest contribution to benefiting patients in China and facilitating surgical procedures for physicians.”

Ensheng Medical possesses robust independent R&D capabilities. Focusing on the venous sector, including varicose veins (VV), iliac vein compression syndrome (IVCS), deep vein thrombosis (DVT), and pulmonary embolism (PE), the company has developed several innovative projects aimed at creating comprehensive solutions. Currently, two core products have entered clinical trials, with venous stents expected to receive regulatory approval within one year. Furthermore, leveraging its three major platforms—modular stent design, biomedical materials, and active medical devices—the company is committed to becoming a leading enterprise in the peripheral vascular field.

Shanghai Ensheng Medical Technology Co., Ltd., established in November 2018, is a high-tech medical innovation enterprise with independent intellectual property rights. The company specializes in the research, development, and industrialization of vascular medical devices at an internationally advanced level. Leveraging three core platforms—modular stent design, biomedical materials, and active medical devices—it aims to become a comprehensive provider of solutions for peripheral vascular diseases, committed to delivering high-end medical devices that benefit clinicians and patients alike. Its core team members possess extensive R&D and management experience from renowned medical device companies both in China and abroad.

Ensheng Medical's headquarters is located in the Lanwan Life Science and Technology Park within the Lingang Free Trade Zone in Shanghai, China. The company has obtained ISO 13485 international quality system certification and has established R&D, production, and office facilities that meet GMP Class 10,000 cleanroom standards.

Since its establishment, Ensheng Medical has received support and encouragement from multiple technology funds in Shanghai, Pudong New Area, and the Lingang Special Area. It has also been honored with titles such as “Shanghai High-Tech Enterprise,” “First Prize in the National Finals of the 4th Medical Device Innovation and Entrepreneurship Competition,” and “Rising Star of Shanghai Lingang Special Area.” Currently, Ensheng Medical has secured venture capital investment from well-known domestic medical venture capital firms.