Multi-center study to evaluate safety and efficacy of S.M.A.R.T. RADIANZ™ Vascular Stent System via Radial Access
MIAMI LAKES, Fla., July 14, 2022 /PRNewswire/ — Cordis, a global leader in cardiovascular technologies, today announced the start of the RADIANCY pre-market clinical study in Europe. It is a prospective, multi-center, single-arm study to assess the 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.
The first procedure was performed by Dr. Mercedes Guerra, Chief of Angiology, Vascular and Endovascular Surgery at the University Hospital of Guadalajara in Spain, using the BRITE TIP RADIANZ™ Guiding Sheath and SABERX RADIANZ™ PTA Balloon Catheter to facilitate delivery of the S.M.A.R.T RADIANZ™ self-expanding stent in an iliac lesion.
Upon completion of the procedure, Dr. Guerra said, “My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study. We applaud Cordis for pursuing the technological innovation to meet the need for radial access solutions in lower extremity interventions. We look forward to contributing our findings to the global endovascular community as part of the RADIANCY clinical study.”
The RADIANCY study, led by Principal Investigator Raphaël Coscas MD, PhD, Professor of Vascular Surgery at Ambroise Paré Hospital in France, is planned to enroll 159 patients at approximately 15 sites across seven European countries. “The RADIANCY study initiation marks a new course for the future management of patients with Peripheral Arterial Disease (PAD) by expanding their treatment options from current conventional femoral to radial access,” Professor Coscas said.
Professor Coscas also highlighted the era of practice evolution in this space, “As the gold-standard approach in coronary interventions, radial is in its exciting inception phase for PAD and offers unequivocal patient-centric advantages in terms of early mobility and comfort, critical in both in-patient and out-patient practice settings.”
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 earlier this year, and successful first-in-human procedures were performed in June 2022 by Dr. Jihad Mustapha, Chief Executive Officer and Director of Endovascular Intervention at Advanced Cardiac & Vascular Centers (ACV) for Amputation Prevention, in Grand Rapids, Michigan.
Dr. George Adams, Cordis Chief Medical Officer, said, “Cordis is committed to developing tools to treat complex PAD patients. Understanding the real-world, 10-year S.M.A.R.T.® Vascular Stent System data combined with the innovation of a radial approach allows the interventionalist to treat PAD safely, efficaciously, and cost effectively. Mirroring this innovation with research and a strong educational program to advance the field is truly at Cordis’ core.”
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CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
The S.M.A.R.T. RADIANZ™ Vascular Stent System is NOT CE marked and not yet available for sale in Europe and other countries. In Europe, the S.M.A.R.T. RADIANZ™ Vascular Stent System is exclusively for clinical investigations. CORDIS, Cordis LOGO, S.M.A.R.T., S.M.A.R.T. RADIANZ, SABERX RADIANZ, BRITE TIP RADIANZ and Radianz Radial Peripheral System are trademarks of Cordis and may be registered in the US and/or in other countries. ©2022 Cordis. All Rights Reserved.
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 Balloon 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. The study plans to enroll 159 subjects approximately 15 investigational sites in seven European countries.
About the Products
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 – including the first and only self-expandable stent indicated for iliac lesions with a radial delivery system. The portfolio includes BRITE TIP RADIANZ™ Guiding Sheath, the first multi-segmented thin-walled guiding sheath specifically designed to optimize lower-extremity lesion access from a radial approach. SABERX RADIANZ™ Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter features the most clinically 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.
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