Cordis, a global leader in cardiovascular technologies, today announced the start of the RADIANCY pre-market clinical study in Europe.
| 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.” For healthcare professionals only. About Cordis About the RADIANCY Clinical Study About the Products Media contact:
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