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November 11, 2013
Veniti Receives CE Mark Approval for Vici Venous Stent
November 6, 2013—Veniti, Inc. (St. Louis, MO) has received European CE Mark approval for the Veniti Vici venous stent, specifically designed for the treatment of venous obstruction. The company also received CE Mark approval for the Veniti Veni RF Plus varicose vein ablation system.
According to Veniti, the Vici venous stent is designed and intended from its inception as a dedicated venous stent. The device combines end-to-end crush resistance, flexibility, and continuous vein wall coverage, making it well-suited for the treatment of iliofemoral venous obstruction. The company advised that it is seeking US Food and Drug Administration (FDA) approval to begin clinical studies of the Veniti Vici venous stent in the United States.
The Veni RF Plus ablation system is designed to heat saline into vapor, 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.
The Veniti Vidi vena cava filter is in early stages of clinical studies in New Zealand, and the company is seeking approval from the FDA to begin clinical studies of the Vidi vena cava filter in the United States.
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