Cordis announced that it began the Radiancy pre-market clinical study of its vascular stent system for treating lesions.
Miami Lakes, Florida-based Cordis’ prospective, multi-center, single-arm study in Europe will assess the safety and efficacy of the SMART Radianz vascular stent system for the treatment of lesions in the iliac, superficial femoral or proximal popliteal arteries via radial artery access through 30-day follow-up.
According to a news release, Dr. Mercedes Guerra, the chief of angiology, vascular and endovascular surgery at the University Hospital of Guadalajara in Spain, performed the first procedure. That procedure was performed using the Brite Tip Radianz guiding sheath and the SaberX Radianz PTA balloon catheter to facilitate the delivery of the SMART Radianz self-expanding stent in an iliac lesion.
“My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study,” Guerra said in the release. “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.”
Dr. Raphaël Coscas, professor of vascular surgery at Ambroise Paré Hospital in France, is leading the study as principal investigator. Cordis expects the study to enroll 159 patients across approximately 15 sites in 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,” Coscas said. “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.”
Cordis’ SMART Radianz vascular stent system was approved for use in the U.S. earlier this year, with successful first-in-human procedures performed last month in Michigan.
“Cordis is committed to developing tools to treat complex PAD patients,” Cordis CMO Dr. George Adams said. “Understanding the real-world, 10-year SMART 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.”