Image Courtesy of Covidien
November 18, 2014 — Covidien announced results of the durability Iliac study and addition of the iliac indication for its EverFlex stent at the Vascular Interventional Advances (VIVA) 2014 conference. The nine-month results confirm the safety and effectiveness of the EverFlex and Protégé GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries.
The prospective, multi-center, non-randomized clinical study included 75 patients at 15 centers in the United States and Europe. Nearly 68 percent of patients in the trial had moderately to severely calcified lesions. The study demonstrated 100 percent device success, and the primary endpoint was met with no major adverse events (MAE) at 30 days and a MAE rate of 1.3 percent at nine months.
The nine-month primary patency by Kaplan-Meier analysis (the ability for the treated artery to remain open) was 95.8 percent, and freedom from target vessel revascularization (no repeat procedure) was 98.6 percent. Patient quality of life was also evaluated using two common screening tools for peripheral vascular disease, an Ankle Brachial Index and Walking Impairment Questionnaire.
The EverFlex and Protégé GPS self-expanding stent systems are Nitinol stent systems that expand to a predetermined diameter to restore blood flow. The EverFlex stent received iliac U.S. Food and Drug Administration approval in 2014.
For more information: www.covidien.com