Clearance includes percutaneous and surgical use in superficial and perforator veins.
VCD Medical Receives U.S. FDA 510(k) Clearance for VEnice™ Vein Closure Device
About VEnice™ Vein Closure Device
Brescia, Italy, Sept. 29, 2026 (GLOBE NEWSWIRE) — VCD Medical, an Italy-based company developing novel, minimally invasive vein closure technologies, 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 Americans[i] 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.”
Dr. Elias is scheduled to present interim six-month results from the BERG02 study at The VEINS, October 3–4, 2026, at Bellagio 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.”
About VCD Medical
VCD Medical is an Italy-based medical technology company focused on advancing innovation in the treatment of diseased venous vessels. The company has developed a novel, minimally invasive vascular clip technology intended to simplify vein closure procedures and support clinical workflow efficiency. VCD Medical is committed to rigorous development, responsible evidence generation, and future access to technologies that may help address unmet needs in venous disease care. Learn more at: https://www.vcd-medical.com/.
Media Contact
Lisa Owens
Bichsel Medical Marketing Group
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[i] 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
Attachments
- VCD Medical Receives U.S. FDA 510(k) Clearance for VEnice™ Vein Closure Device
- About VEnice™ Vein Closure Device
CONTACT: Francesco Piccagli, PhD VCD Medical +39 345 4808994 [email protected]
