VCD Medical Received FDA Clearance for VEnice Device
The FDA authorized the sale of the VEnice vein closure system for treating venous disease in the United States.
Updated on Sept. 29, 2026 in Stroke
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VCD Medical has received 510(k) clearance from the FDA to market its VEnice device in the U.S. The technology offers a minimally invasive, nonthermal method for managing venous disease by mechanically closing superficial or perforator veins.
Why it matters
The clearance introduces a new tool for addressing venous conditions without thermal energy. This provides an alternative option for patients suffering from varicose veins, a condition that currently affects 40 million Americans.
The VEnice device utilizes a 17-gauge needle applicator to deliver a pre-loaded implantable clip for vein occlusion. The system features an integrated suture cutter designed for real-time ultrasound-guided deployment.
The players
VCD Medical
Headquartered in Brescia, Italy, this company specializes in developing medical technology for vascular intervention.
Dr. Steve Elias
A medical professional scheduled to present interim findings from the BERG02 clinical study.
The details
The VEnice device functions by compressing and occluding target veins using a pre-loaded clip. This process allows physicians to perform mechanical vein closure through a minimally invasive procedure using the integrated cutter.
Timeline
September 29, 2026: VCD Medical received FDA 510(k) clearance.
October 3-4, 2026: Interim BERG02 study results will be presented at The VEINS in Las Vegas.
The Big Picture
This clearance follows the established FDA 510(k) clearance pathway, which mandates that new devices must demonstrate substantial equivalence to previously approved technologies to enter the market. The authorization reflects the ongoing evolution of minimally invasive vascular surgical tools.
The introduction of this device provides patients with a nonthermal alternative for treating venous conditions. This may result in new clinical options that influence routine treatment plans for those managing varicose veins.
The takeaway
The clearance of the VEnice device represents a transition toward mechanical, nonthermal treatment options in vascular care. Patients should consult with their healthcare providers to determine if this new modality is an appropriate treatment for their specific venous health needs.
What happens next
Dr. Steve Elias is scheduled to present interim six-month results from the BERG02 study on October 3-4, 2026, at The VEINS conference in Las Vegas, Nevada.
Further reading
Learn more about the latest innovations in vascular health at our Stroke section.
More information
For more information on the device specifications, visit the VCD Medical company website.
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