The FDA has approved C.R. Bard's E.Luminexx Vascular Stent, the company said on Monday. The device is a flexible, self-expanding stent for patients with common or external iliac artery occlusive disease. Current estimates indicate that each year more than 140,000 patients are candidates for iliac stent procedures in the US, Bard officials said.
This patient population is expected to grow by more than 10 percent annually as a result of the increased focus on treating peripheral arterial disease and the growing number of diabetic patients who are at higher risk of developing these occlusions, the company said.
Bard's prospective, multi-center, non-randomized, clinical study of 134 patients measuring the E.Luminexx vascular stent against objective performance criteria demonstrated an anatomic success rate of 98.72%.
Timothy M. Ring, Bard's chairman and chief executive officer, said that the E.Luminexx vascular stent joins the Flair endovascular stent graft approved in October as a treatment for stenosis in dialysis bypass grafts.
Bard is now the only medical device maker in the U.S. offering both a stent and a stent graft with peripheral vascular indications, Ring said.