US-based Veniti has received US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) to initiate the virtus trial of the Veniti VICI venous stent system.
The company said that the Veniti VICI venous stent system was designed to be compatible with the unique anatomy and pathophysiology of the venous system.
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The only treatment options available to treat lower-extremity venous disease involved the use of re-purposed vascular stents originally designed for use in the arterial system.
Co-principal investigator of the Virtus trial William Marston said: "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.
"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."
St Joseph Hospital’s Heart and Vascular Center clinical trials and research director Mahmood Razavi said: "Due to the absence of vein-specific stents, physicians have thus far been using stents that were not designed for veins.
"We look forward to the completion of this important study and availability of optimal stents to treat our patients with deep vein obstructive lesions."
The trial has started in Europe, with first patients enrolled and treated at Hospital Madrid Monteprincipe in Madrid, Spain.
Veniti president and chief executive officer Scott Solano 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."
