VCD Medical Receives FDA Clearance for VEnice™ Vein Closure Device

Brescia, Italy, Sept. 29, 2026 /CourierPR/ -- VCD Medical, an Italy-based company focused on advancing innovation in the treatment of diseased venous vessels, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VEnice™ Vein Closure Device. This marks a significant milestone for the company, allowing it to commercialize the device in the U.S. market.

Varicose veins affect as many as 40 million Americans, with hundreds of thousands of procedures performed annually. VCD Medical's VEnice™ Vein Closure Device addresses this large and growing market through a minimally invasive, nonthermal method to treat veins. The device 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. This allows for real-time, ultrasound-guided deployment of clips to compress and occlude the target vein, offering a simpler and faster alternative to traditional treatments.

Dr. Steve Elias, director of the Center for Vein Disease at Englewood Health Network, commented on the significance of the VEnice™ technology.

Dr. Elias is scheduled to present interim six-month results from the BERG02 study at The VEINS conference, which will take place on 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.

Francesco Piccagli, PhD, Chief Executive Officer of VCD Medical, expressed his excitement about the FDA clearance.