FDA Cleared New Vein Closure Device

The VEnice system offers a new minimally invasive option for people in the U.S. seeking treatment for varicose veins.

Updated on Sept. 29, 2026 in Stroke

Bold flat-color editorial illustration of a surgical needle and vascular forms, evoking the precision of modern medical vein closure devices. — The FDA has granted 510(k) clearance to the VEnice system, a new minimally invasive, nonthermal device for the treatment of varicose veins. AI Illustration. Upload story photo >

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The FDA has granted 510(k) clearance to the VEnice vein closure device for commercial use in the United States. The system provides a new minimally invasive, nonthermal method for managing venous disease.

Why it matters

This device offers an alternative for the estimated 40 million Americans living with varicose veins by providing a nonthermal treatment option. It addresses the need for less invasive procedures in managing chronic venous insufficiency.

The FDA 510(k) clearance recognizes the safety and efficacy of the VEnice device based on regulatory submission data. While this enables commercial use, the full outcomes of the ongoing BERG02 study remain under evaluation.

The players

VCD Medical

An Italy-based medical device company that develops nonthermal solutions for treating venous disease.

Dr. Steve Elias

A medical professional and researcher who will present interim findings from the BERG02 clinical study.

The details

The VEnice device works by mechanically compressing and occluding target superficial or perforator veins. Practitioners deploy a pre-loaded implantable clip using a small 17-gauge needle applicator. The system also features an integrated suture cutter to facilitate precise, real-time ultrasound-guided deployment during the procedure.

September 29, 2026: VCD Medical received FDA 510(k) clearance.
October 3-4, 2026: Dr. Steve Elias will present interim BERG02 study results.

Health Landscape

The introduction of the VEnice device fits into the broader shift toward nonthermal, minimally invasive procedures for vascular conditions. It follows the developmental trajectory of the ongoing BERG02 study, which continues to evaluate clinical performance in venous interventions.

For those managing varicose veins, this development expands the range of minimally invasive tools available to clinicians. If you are exploring treatment options, discuss whether nonthermal procedures are appropriate for your specific venous health with your doctor.

The takeaway

The FDA clearance of the VEnice system provides a new nonthermal option for addressing venous disease. Patients interested in minimally invasive vein treatments should ask their vascular specialist about the latest procedural advancements available in their area.