FDA approves IDE for VENITI VICI Venous Stent System
Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.
Co-Principal Investigators for the VIRTUS Trial are William Marston, M.D., chief, Division of Vascular Surgery, professor, Department of Surgery, UNC Department of Surgery, Chapel Hill, N.C., and Mahmood Razavi, M.D., director for Clinical Trials & Research at the Heart and Vascular Center, St. Joseph Hospital, Orange, Calif.
"Obstruction of the iliac veins and vena cava have been identified as a frequent cause of severe venous disease resulting in major disabling symptoms including leg swelling, pain and ulceration," said Marston. "The development of stents specifically designed for the unique characteristics of the venous system provide the potential to reduce these debilitating symptoms for patients, while improving the cost effectiveness of interventional treatment for venous obstruction."
The trial has commenced in Europe, with first patients enrolled and treated by Marta Ramirez Ortega, M.D. at Hospital Madrid Monteprincipe in Madrid, Spain.
Scott Solano, Veniti president and CEO, said, "The unique advantages of a stent designed specifically for the venous system, including end-to-end crush resistance, flexibility and continuous vein coverage, may offer significant patient benefit."