Nine-month results of VISIBILITY Iliac study presented at EuroPCR 2014

Covidien today announced nine-month data from the VISIBILITY Iliac study, which confirms the safety and effectiveness of the treatment of lesions of the common and external iliac arteries with the Visi-Pro(tm) balloon-expandable stent system. Results were presented by co-National Principal Investigator John Rundback, MD, Holy Name Medical Center, Teaneck, N.J., during an oral presentation this week at EuroPCR Scientific Congress in Paris.

Iliac stenosis, or narrowing of the iliac artery, can affect the blood supply to the leg and may result in pain, limited physical mobility and non-healing leg ulcers. The Visi-Pro stent system utilizes a balloon-expandable stent that helps patients regain blood flow.

"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. "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. 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."

The prospective, multi-center, non-randomized study enrolled 75 patients at 17 centers in the United States (U.S.) and Europe. The study met its primary endpoint, with major adverse event  rate of four percent at nine months. Additionally, the technology achieved 100 percent device success, and primary patency and freedom from clinically-driven target lesion revascularization at nine months was both 95.8 percent respectively.

"The results of the VISIBILITY Iliac trial confirms that the Visi-Pro stent system is safe and effective in treating patients with iliac stenosis," said Mark A. Turco, MD, chief medical officer, Vascular, Covidien.  "We look forward to longer term follow-up out to three years of this balloon expandable stent platform."*

*Visi-Pro stent system is currently approved in Europe for peripheral use and cleared in the U.S. for biliary use. In the U.S., Visi-Pro stent is currently not indicated for iliac stenosis. The results of the VISIBILITY Iliac trial will be used to support a pre-market approval submission to the U.S. Food and Drug Administration for an iliac indication.