St. Louis-based Veniti Medical has been granted CE Mark approval for its VICI Venous stent, used to treat occluded iliofemoral veins, as well as the Veniti Veni RF Plus Ablation System, for varicose veins. Despite the prevalence of venous disease states, medical technology was almost exclusively designed for the arterial side and then transferred to the venous side, often without consideration for anatomy or physiology. The VICI was conceived with the venous side in mind, constructed from self-expanding Nitinol and designed with both high radial strength and flexibility. Coupled with a bidirectional delivery system, the VICI will give physicians better accuracy and more options in terms of placement.
The Veni RF Plus system can be used to treat the approximately 20 million Americans suffering from venous insufficiency. It works by vaporizing saline solution to ablate the veins, eliminating the need for compression of the vein. Veniti also anticipates other varicosities will be eliminated as the saline vapor travels beyond the application point.
Veniti Medical will continue studies for the VICI venous stent and will apply for FDA approval upon completion of clinical trials.
Press release: Veniti(TM) Receives CE Mark Approval for Vici Venous Stent…