Veniti has obtained the US Food and Drug Administration’s (FDA) investigational device exemption (IDE) approval to initiate the Virtus trial of its Veniti VICI venous stent system.
The company has designed the VICI venous stent system from inception to be compatible with the anatomy and pathophysiology of the venous system.
Dr William Marston from UNC Department of Surgery and Dr Mahmood Razavi from St. Joseph Hospital are acting as co-principal investigators for the VIRTUS trial.
The Virtus trial was initiated in Europe, with first patients enrolled and treated by Dr Marta Ramirez Ortega at Hospital Madrid Monteprincipe in Madrid, Spain.
Dr Ortega said: "It is important for my patients to be able to be treated with a stent specifically designed for the venous anatomy and for them to have their data collected so that future patients can benefit from knowing how well venous stenting works."
Veniti president and CEO Scott Solano said that the company is very pleased with the approval of the IDE and excited to be conducting this important research with physicians in both Europe and the US.
"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," Solano added.