Veniti receives CE Mark approval for Vici Venous Stent

Veniti(TM), Inc. (Veniti), has received approval to CE Mark the Veniti Vici(TM) Venous Stent, specifically designed for the treatment of venous obstruction. In addition, the company received CE Mark approval for their varicose vein ablation product, the Veniti Veni(TM) RF Plus Ablation System. The CE Marks allow Veniti to sell products within the European Union.

The Vici Venous Stent is the first stent designed and intended from its inception as a dedicated venous stent. "We believe the unique combination of end-to-end crush resistance, flexibility and continuous vein wall coverage make the Vici Venous Stent particularly well-suited for treating iliofemoral venous obstruction," commented Scott Solano, Veniti President and Chief Executive Officer.

"After many years of using re-purposed arterial stents to treat this serious disease that affects so many people, we are excited to offer physicians a stent designed specifically for iliofemoral venous obstruction," noted Solano. "We are eager to demonstrate the Vici Venous Stent advantages to physicians and to provide them with a venous-specific stent."

The company is seeking U.S. Food and Drug Administration approval to begin clinical studies of the Veniti(TM) Vici Venous Stent in the United States.

The Veni RF Plus Ablation System is a patented system for heating saline to vapor and utilizing the phase change energy to ablate varicose veins. Using steam in the ablation process eliminates the need to compress the vein around the heat source, and provides nominal application of energy.