A Medical Device Daily
C.R. Bard (Murray Hill, New Jersey) said it has received FDA approval to market the E•Luminexx vascular stent. The device is a flexible, self-expanding nitinol stent to be marketed by the Bard Peripheral Vascular Division (Tempe, Arizona).
The E•Luminexx vascular stent is intended to treat 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 U.S. This patient population is expected to grow by more than 10% annually due to the increased clinician focus on treating peripheral arterial disease and the growing number of diabetic patients who are at higher risk of developing such occlusions.
Chairman/CEO Timothy Ring said, "The E•Luminexx Vascular Stent joins the recently approved Flair endovascular stent graft to position Bard as the only medical device company offering both a stent and a stent graft with peripheral vascular indications in the U.S. The anticipated approval of the LifeStent FlexStar stent for the treatment of superficial femoral artery disease will further enhance our comprehensive offerings to address challenges associated with the treatment of peripheral vascular disease."