FDA cleared VCD Medical's VEnice vein closure device on September 29. The indication covers percutaneous and surgical closure of superficial and perforator veins in patients with varicose veins.

VEnice deploys a pre-loaded implantable clip through a 17-gauge needle applicator under ultrasound guidance, compressing the vein shut. The handheld applicator carries an integrated suture cutter. No thermal energy is involved, which places it outside both the ablation and sclerotherapy categories that own the indication today.

A mechanical closure with no generator and no tumescent anesthesia is a different reimbursement and site-of-service argument than radiofrequency or laser, and that is the part US payers will decide. Interim six-month results from the BERG02 study of percutaneous ligation with sclerotherapy are due at The VEINS meeting in October.

VCD Medical is based in Brescia, Italy, and was founded in 2021. It named Denna Babul US general manager in May.