Executive Summary

Edwards Lifesciences has begun a US trial to assess its self-expanding stent, LifeStent NT, as a treatment for peripheral vascular disease. The RESILIENT study, which will involve around 220 patients at up to 25 medical centres throughout the country, differs from similar investigations because it is intended to demonstrate superiority, rather than equivalence, of the device over angioplasty in treating blockages in the superficial femoral artery (SFA) and popliteal artery, says the Irvine, California firm. The LifeStent system comprises a helical structural scaffold designed to withstand the continual bending and flexing experienced in the SFA. The company, which is also looking to CE-mark the product in Europe for the peripheral vascular disease indication, has already received US market clearance to use the device for treating biliary obstructions.