Expandable Arterial Stent Helps Treat Iliac Stenosis

A balloon-expandable stent system helps patients regain blood flow by treating lesions of the common and external iliac arteries.

The Visi-Pro balloon-expandable stent system is intended to improve and maintain artery luminal diameter in occlusions or lesions at high risk for abrupt closure following percutaneous transluminal angioplasty (PTA), or in lesions believed to be at high risk of stenosis following PTA in the common and external iliac, subbclavian, and renal arteries. The stent is also indicated for use as a palliative treatment of malignant neoplasms in the biliary tree.

The Visi-Pro is made from a 316L stainless steel tube with a diameter of 0.9 mm cut into an open lattice design; tantalum radiopaque markers are placed at the proximal and distal ends of the stent for guided placement. For delivery, the stent is mounted onto a tightly-folded balloon catheter, and then expanded and deployed by inflating the balloon. Other features include solid radial strength, flexibility, superior trackability, and a unique 5-fold balloon wrap that improves retraction.

In a prospective, multicenter, nonrandomized study that enrolled 75 patients at 17 centers in the United States and Europe, The Visi-Pro met its primary nine month endpoint, with a major adverse event rate of just 4%. Additionally, the technology achieved 100% device success, with primary patency and freedom from clinically-driven target lesion revascularization at nine months at 95.8%. The Visi-Pro is a product of Covidien (Dublin, Ireland), and has received the European Community CE marking of approval.

“The nine month results were positive, demonstrating the effectiveness of the technology in treating patients with iliac disease, regardless of gender, lesion location, or severity,” said lead author John Rundback, MD, of the Holy Name Medical Center (Teaneck, NJ, USA). “A unique benefit of the Visi-Pro stent is its excellent visibility during deployment, which optimizes precise positioning and minimizes the risk of geographic miss that is inherent to iliac stent procedures.”

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