US-based medical device company Veniti has obtained CE Mark approval for its Veniti Vici venous stent, designed for venous obstruction treatment.
The company has also obtained CE Mark approval for its Veniti Veni RF plus ablation system, a varicose vein ablation product.
Veniti is currently seeking approval from the US Food and Drug Administration to initiate clinical studies of the Veniti vici venous stent in the US.
The patented Veni RF plus ablation system will heat saline to vapor and uses the phase change energy to ablate varicose veins.
Using steam in the ablation process provides nominal application of energy, while eliminating the need of compressing the vein around the heat source.
Veniti president and CEO Scott Solano noted the company believes 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.
"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.
"We are eager to demonstrate the Vici Venous Stent advantages to physicians and to provide them with a venous-specific stent," Solano added.
With this approval, Veniti can now sell the products in the EU.
