Covidien's EverFlex stent has met safety and efficacy endpoints in the one-year study evaluating the use of stent for superficial femoral artery stenting.
The Durability II study of EverFlex stent enrolled 287 subjects with lesions up to 18 cm in length at 44 investigational sites in both the US and Europe.
The EverFlex stent system will allow physicians to treat long lesions in peripheral arterial diseased (P.A.D.) patients with a single stent, reducing the occurrence of stent fractures.
The primary endpoints of the trial included 30-day major adverse event rate and primary patency at one year.
Following one-year, EverFlex stent reported primary patency of 67.7% when analysed by simple proportions of patient’s patent, and 77.2% while using Kaplan-Meier time-to-event analysis.
The study also demonstrated stent fracture rate of 0.4% at one-year.
Co-National principal investigator of study Jon Matsumura said the study evaluated that a novel longer stent system provides the option of single stent treatment of extensive symptomatic femoral artery disease.