Venous disease specialist company, Veniti™, Inc., has gained U.S. FDA approval for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The company says its system was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system.
Background
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. Veniti says its Vici Venous Stent System is designed specifically for the treatment of venous outflow obstruction. With a large diameter, high radial strength, flexibility and use of a bidirectional delivery system, the device is anticipated to facilitate accurate placement while providing the physician numerous delivery options.
Investigator comments
Investigator William Marston, M.D., Chief, Division of Vascular Surgery, Professor, Department of Surgery, UNC Department of Surgery, Chapel Hill, NC stated; “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 Dr. Marston. He added, “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.”
Investigator Mahmood Razavi, M.D., Director for Clinical Trials & Research at the Heart and Vascular Center, St. Joseph Hospital, Orange, CA stated; “This is an important landmark for VENITI and patients with deep venous disease. 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 system is already approved for use in Europe. Indeed the trial has already commenced, with first patients enrolled and treated by Marta Ramirez Ortega, M.D. at Hospital Madrid Monteprincipe, who stated; “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.”
Company comments
“We are very pleased with the approval of our IDE and excited to be conducting this important research with physicians in both Europe and the U.S.” said Scott Solano, VENITI President and Chief Executive Officer. “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.”
Source: Veniti, Inc., PR Newswire
published: July 14, 2014 in: Approval/Clearance, Clinical Studies/Trials, Vascular