S.M.A.R.T. Radianz vascular stent system approved for transradial use in the USA


Cordis recently announced that the US 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. 

The newly approved vascular stent system joins the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal angioplasty (PTA) catheter to complete the Radianz radial peripheral system, a company press release notes.

According to Cordis, the safety and efficacy profile of S.M.A.R.T. vascular stents is validated with a solid foundation of clinical evidence and real-world experience. It claims that the S.M.A.R.T. vascular stents are the only SE lower extremity stents with 10-year follow-up, proven to provide reliable outcomes in over 3,000 patients, and that they have shown comparable one-year revascularisation rates and a significantly lower cost of hospitalisation versus drug-coated stents.

“I am excited that Cordis has committed to delivering new interventional tools that can be utilised in treating patients with cardiac or vascular disorders via a transradial access,” said Craig M Walker, president and founder of the Cardiovascular Institute of the South (Houma, USA). “We have been constrained in the greater utilisation 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 utilisation of radial access in treating patients.”

Cordis advises that the S.M.A.R.T. Radianz vascular stent 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 superficial femoral artery (SFA) lesion treatment, and the rapid exchange delivery system offers more convenient wire management and device exchange compared with over-the-wire (OTW) catheter systems, the company adds.

“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.”


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