Nine-Month Data From Covidien's VISIBILITY Iliac Stenting Study Presented at EuroPCR

May 23, 2014—Covidien has announced that 9-month data from its VISIBILITY Iliac study were presented at EuroPCR 2014 in Paris. The data from this evaluation of the Visi-Pro balloon-expandable stent were presented by John Rundback, MD.

“The objective of the VISIBILITY Iliac study was to confirm the safety and effectiveness of the Visi-Pro stent system in the treatment of lesions in the common and external iliac artery,” said Dr. Rundback in a press release. Dr. Rundback, of Holy Name Medical Center in Teaneck, New Jersey, serves as co-National Principal Investigator of VISIBILITY. 

“The 9-month results were positive, demonstrating the effectiveness of the technology in treating patients with iliac disease, regardless of gender, lesion location or severity,” continued Dr. Rundback. “Additionally, 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.”

Covidien describes VISIBILITY as a prospective, multicenter, nonrandomized study enrolling 75 patients at 17 centers in the United States and Europe. The study is reported to have met its primary endpoint, with a major adverse event rate of 4% at 9 months. Device success was 100%, and the rates of primary patency and freedom from clinically driven target lesion revascularization at 9 months were both 95.8%.

Visi-Pro is approved for peripheral use in Europe and cleared for biliary use, but not currently indicated for iliac stenosis, in the United States. The results of VISIBILITY are intended to support a pre-market approval submission for an iliac indication from the US Food and Drug Administration.