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Devices Interventional FDA

 News Release - March 10, 2022

S.M.A.R.T. RADIANZ(TM) Vascular Stent System Approved for Transradial Use in the U.S.

Completes the RADIANZ Radial Peripheral System™; signals Cordis' renewed investment in innovation

MIAMI LAKES, Fla., March 10, 2022 -- (Healthcare Sales & Marketing Network) -- Cordis, a global cardiovascular technology company, today 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.

The newly approved vascular stent system joins the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Catheter to complete the RADIANZ Radial Peripheral System™, specifically designed to optimize radial access, deliver exceptional outcomes, and high levels of patient satisfaction. 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 S.M.A.R.T.® Vascular Stents is validated with a solid foundation of clinical evidence and real-world experience. 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. 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."

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 SFA lesion treatment. The rapid exchange delivery system offers more convenient wire management and device exchange compared with over-the-wire (OTW) catheter systems.

"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."

Advanced treatment solutions like the RADIANZ Radial Peripheral System™ offer patients suffering from peripheral artery disease (PAD) new hope in preventing advanced stages of the disease, including ulceration that can lead to amputation when left untreated. According to the American Heart Association, over 8.5 million Americans suffer from PAD.

About Cordis

Cordis is a worldwide leader in the development and manufacturing of interventional cardiovascular technologies with a more than 60-year history of pioneering breakthrough therapies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and minimally invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world.


Source: Cordis

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