Miami Lakes, FL, November 16, 2023 – Cordis, a global leader in cardiovascular technologies, has announced the completion of patient enrollment in the RADIANCY Pre-market Clinical Study. The prospective, multi-center, single arm study is designed to evaluate the safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Dilatation Catheter for treatment of iliac and femoropopliteal artery lesions via radial artery access. Data from the RADIANCY Study will be part of the clinical evidence towards pursuing the CE Mark of the S.M.A.R.T. RADIANZ™ Vascular Stent System.
The RADIANCY Study enrolled 151 subjects at 12 sites across six European countries. The results of the first 100 subjects were presented at Paris Vascular Insights on Nov 9, 2023, by lead Principal Investigator, Raphaël Coscas MD, PhD, Professor of Vascular Surgery at Ambroise Paré Hospital in France. Prof. Coscas commented, “The results are very exciting and promising with excellent technical success (97.9%) and a great safety profile. These results attest to the technological innovation and patient advantages for PAD treatment in terms of early mobility and safety. I applaud Cordis for a successful completion of this trial and strengthening the scientific evidence for radial to peripheral procedures.” The final results of the study are awaited.
“The transradial approach has been established as the standard access site in cardiology, with proven patient benefits such as less risk of complications at access site (bleeding, hematoma, groin infection), increased patient comfort, quicker time to ambulation/mobility of patients, and earlier discharge. With the Radianz Radial Peripheral System™ portfolio, we are proud to contribute to expanding these benefits to patients undergoing peripheral interventions,” added Dominique Boulet, President of Cordis EMEA.
The S.M.A.R.T. RADIANZ™ Vascular Stent System, specifically engineered for radial access, was approved for use in the United States by the FDA in February 2022, and in Japan by PMDA in March 2022.
Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and less-invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world.
About the RADIANCY Clinical Study
RADIANCY is a prospective, multi-center, single-arm study to assess safety and efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System intended for treatment of lesions in the iliac, superficial femoral or proximal popliteal arteries via radial artery access through 30-day follow up when used with the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Dilatation Catheter. Both the stent and balloon are specifically engineered with a rapid exchange design and improved shaft pushability to optimize radial access delivery, and deployment.
About the Products
The Cordis Radianz Radial Peripheral System™ is purposely engineered to deliver exceptional outcomes and a high level of patient satisfaction with tools optimized for radial access and treatment. The portfolio includes BRITE TIP RADIANZ™ Guiding Sheath, a multi-segmented thin-walled guiding sheath specifically designed to optimize lower-extremity lesion access from a radial approach available in 110cm and 135cm shaft lengths. SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter features a comprehensive radial peripheral PTA size matrix to facilitate broader treatment of lesions. S.M.A.R.T. RADIANZ™ Vascular Stent System treats iliac, superficial femoral artery, and proximal popliteal lesions from the radial approach. It is the first radial peripheral self-expanding stent indicated for iliac lesions.