Covidien Begins DURABILITY and VISIBILITY Iliac Studies

August 4, 2011—Covidien (Mansfield, MA) announced the commencement of enrollment in the DURABILITY Iliac and VISIBILITY Iliac studies. Marc Bosiers, MD, enrolled the initial patients in the DURABILITY Iliac study, and Patrick Peeters, MD, enrolled the first patient in the VISIBILITY Iliac study.

According to Covidien, the studies are prospective, multicenter, nonrandomized studies designed to confirm the safety and effectiveness of the company's stent systems for treating disease in the common and/or external iliac arteries. The DURABILITY Iliac study will evaluate Covidien's Protégé EverFlex self-expanding stent system and the Protégé GPS self-expanding nitinol stent and delivery technology. The VISIBILITY Iliac study will evaluate Covidien's Visi-Pro balloon-expandable stent system. Each study will enroll 75 patients at up to 20 sites in Europe and the United States. The Principal Investigators are Peter Faries, MD, and John Rundback, MD.

“The DURABILITY Iliac and VISIBILITY Iliac studies are highly significant,” commented Dr. Faries. “These trials will evaluate the effectiveness of three outstanding stents used to treat iliac artery occlusive disease, providing additional evidence of peripheral stenting as a recognized standard in the treatment of iliac artery diseases.”

Dr. Rundback added, “They represent unique companion studies for patients with a diverse range of symptomatic iliac atherosclerotic disease. Often, complex patient anatomic patterns exist that may support preferential treatment with one stent system compared to another; the availability of data on these different and complementary stents in comparable patient populations will improve the ability to make confident and evidence-based treatment decisions when caring for these patients.”

The company advised that the Visi-Pro, Protégé EverFlex, and Protégé GPS stents are available in the United States for the palliative treatment of malignant neoplasms in the biliary tree.