Vein Closure Device Receives FDA Clearance

Sept. 29, 2026 — VCD Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VEnice Vein Closure Device for commercialization in the U.S.

Varicose veins affect as many as 40 million Americans¹ with hundreds of thousands of procedures performed annually. VCD Medical's technology addresses a large and growing market through a minimally invasive nonthermal method to treat veins. VEnice performs mechanical closure of superficial or perforator veins using a pre-loaded implantable clip in a small handheld 17-gauge needle applicator with an integrated suture cutter, allowing real-time, ultrasound-guided deployment of clips to compress and occlude the target vein.

Steve Elias, MD, director of the Center for Vein Disease at Englewood Health Network and an experienced clinician, educator and investigator in minimally invasive venous care, said, “For many years, we have looked for ways to make venous procedures simpler, more efficient and less invasive for our patients. A percutaneous vessel closure technology has the potential to provide physicians with another tool in their treatment armamentarium. I am excited to see this technology move forward.”

Vein Closure Device Study

Dr. Elias is scheduled to present interim six-month results from the BERG02 study at The VEINS, Oct. 3–4, in Las Vegas. The core-lab adjudicated study evaluates the safety and efficacy of VEnice percutaneous ligation of superficial and perforator veins combined with sclerotherapy.

“FDA clearance of VEnice represents a significant milestone for VCD Medical and marks an important step in our U.S. commercialization plans,” said Francesco Piccagli, PhD, Chief Executive Officer of VCD Medical. “We developed VEnice to offer physicians a percutaneous closure technology platform that is easy and fast to use for immediately enhanced patient comfort. The clearance brings us an important step closer to making our technology available to physicians and patients across the United States.”

“FDA clearance marks an exciting milestone for VCD Medical and opens the door to bringing VEnice to U.S. physicians,” said Denna Babul, U.S. General Manager of VCD Medical. “We’re excited to engage with the vascular community and introduce physicians to a new approach to superficial and perforator vein closure. Our focus is on education, collaboration, and hands-on experience — helping physicians understand how this innovative percutaneous technology can fit into their practices and potentially expand the way they approach venous disease.”

1. Society for Vascular Surgery. “Varicose Veins.” Your Vascular Health, Society for Vascular Surgery, vascular.org/your-vascular-health/vascular-conditions/common-conditions/varicose-veins. Accessed 24 Sept. 2026