Cordis has begun enrolling members for its European-based Radiancy clinical study, according to a press release.
"My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study," Dr. Mercedes Guerra said. "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.
The first procedure deriving from the study was led by Guerra, chief of angiology, vascular and endovascular surgery at the University Hospital of Guadalajara in Spain. The group used Brite Tip Radianz, Guiding Sheath and Saberx Radianz PTA Balloon Catheter, intended to simplify the distribution of the S.M.A.R.T RADIANZ™ self-expanding stent in an iliac lesion.
“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,” a recent press release explains.
The S.M.A.R.T. RADIANZ™ Vascular Stent System for radial access was recently approved by the FDA for use in the United States, and was officially used in June by Dr. Jihad Mustapha, CEO and director of endovascular intervention at Advanced Cardiac & Vascular Centers (ACV) for Amputation Prevention, in Grand Rapids, Michigan.
"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,” Dr. George Adams, Cordis chief medical officer, said. “Mirroring this innovation with research and a strong educational program to advance the field is truly at Cordis' core."