Shanghai Easy-Flow Medical Tech Co., Ltd. (“Easy-Flow™")  has recently announced the commencement of the pre-market clinical trial for its EF-Volga™ Vein Closure System.

The trial, led by principal investigator Prof. Jinsong JIANG of Zhejiang Provincial People's Hospital, is a prospective, multi-center, randomized controlled study. Its objective is to evaluate the safety and effectiveness of the EF-Volga™ Vein Closure System in treating varicose veins in the lower limbs. The trial will enroll over 150 patients who will be randomized 1:1 to either the EF-Volga™ Vein Closure System or a radiofrequency ablation system.

Varicose veins is a degenerative disease resulting from reflux flow and venous hypertension due to defects or dysfunction of the venous system. This condition is more prevalent in the great saphenous vein (GSV). Symptoms include leg pain, fatigue, heaviness, edema, and are associated with dilated tortuous veins, skin changes, or ulceration. Varicose veins can lead to numerous complications such as bleeding, thrombophlebitis, and even life-threatening pulmonary embolism. It is estimated that varicose veins affect over 120 million individuals in China, with a trend towards younger patients.

Treatments for varicose veins have evolved to become less invasive in recent years. Compared to heat-based endovenous treatments, newer options like medical adhesive can avoid thermal injury and achieve similar or more effective results without the need for tumescent anesthesia. These treatments also offer advantages such as a shorter learning curve and procedure time, reduced postoperative pain, and faster recovery to normal activities.

The EF-Volga™ Vein Closure System is designed for the permanent closure of the target vein by delivering specialized medical adhesive and achieving polymerization within the vessel. The delivery system components include a delivery catheter equipped with LED light for precise placement under ultrasound guidance, in conjunction with a marked introducer. The system also includes an extra syringe with a small amount of glue, allowing for flexible injection according to the location and length of the targeted vein.

Zhenghua MIAO, Chairman and General Manager of Easy-Flow™, commented, “We are thrilled that the EF-Volga™ Vein Closure System has successfully entered its clinical trial phase. This significant milestone marks the beginning of Easy-Flow™'s journey into the field of venous disease treatment. In China, a large number of individuals are afflicted with varicose veins, underscoring a substantial need for effective treatment options. Currently, there are no approved medical adhesive products for varicose veins. We look forward to making this new technology available to physicians and their patients, offering a safer and more effective treatment option as soon as possible."