FDA Approves S.M.A.R.T. RADIANZ Vascular Stent System for Radial Peripheral Procedures

The US Food and Drug Administration has approved the S.M.A.R.T. RADIANZ Vascular Stent System for radial peripheral procedures, according to a statement from Cordis.

Announced by Cordis on March 10, the self-expanding stent is designed to be used with the BRITE TIP RADIANZ Guiding Sheath and SABERX RADIANZ PTA Catheter to complete the RADIANZ Radial Peripheral System, which is designed to optimize radial access, deliver exceptional outcomes, and high levels of patient satisfaction.

"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, in the aforementioned statement. "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."

Studied in more than 3000 patients followed for up to 10 years, the safety and efficacy profile used for the application of S.M.A.R.T. Vascular Stents has been well-established, according to Cordis. When used in combination, the S.M.A.R.T. RADIANZ Vascular Stent System is designed to offer improved ergonomics and one-handed deployment capability. Cordis pointed out the product is available in multiple size matrix to support iliac and SFA lesion treatment.

"At Cordis, we see the RADIANZ Radial Peripheral System™ as a best-in-class option for treating peripheral lesions with the added benefit of reducing the cost of care," said Matt Muscari, Cordis President, Americas. "Empowered by our legacy, we are now focused on investing in a future of innovation. We are committed to leading the way in radial access to enable the less-invasive procedures that patients prefer."

More information about Cordis and the S.M.A.R.T. RADIANZ Vascular Stent System can be found on the company website.