Cordis, a global cardiovascular technology company, announced that the U.S. Food and Drug Administration (FDA) has approved the S.M.A.R.T. Radianz Vascular Stent System, a self-expanding stent purposefully engineered for radial peripheral procedures. S.M.A.R.T. Radianz Vascular Stent System facilitates accurate, efficient placement of stents in the iliac and superficial femoral (SFA) arteries.

Radial approaches provide post-procedure complications of less than 1% compared to 2% to 4% with femoral access. Ambulation time is often reduced from hours to minutes.

The safety and efficacy profile of the stents is validated with a solid foundation of clinical evidence and real-world experience. They are the only SE Lower Extremity stents with 10-year follow-up, proven to provide reliable outcomes in over 3,000 patients. S.M.A.R.T. Vascular Stents have shown comparable one-year revascularization rates and a significantly lower cost of hospitalization versus drug-coated stents.

"I am excited that Cordis has committed to delivering new interventional tools that can be utilized in treating patients with cardiac or vascular disorders via a transradial access," said Craig M. Walker, MD, President and Founder of the Cardiovascular Institute of the South. "We have been constrained in the greater utilization of this important access site associated with greater patient comfort and less major bleeding as our diagnostic and interventional tools that can be delivered via this access have been limited. These lower-profile devices should expand the utilization of radial access in treating patients."

The system features improved ergonomics and advanced one-handed deployment capability, offering excellent placement accuracy and up to 300% greater stability. The product is available in a broad size matrix to support iliac and SFA lesion treatment. The rapid exchange delivery system offers more convenient wire management and device exchange compared with over-the-wire (OTW) catheter systems.