Cordis’ SMART Radianz Transradial Vascular Stent System Studied in Europe

July 14, 2022—Cordis announced the start of the RADIANCY premarket clinical study in Europe.

According to the company, RADIANCY is a prospective, multicenter, single-arm study to assess the 30-day safety and efficacy of the SMART Radianz vascular stent system, which is specifically engineered for radial access, and intended for the treatment of lesions in the iliac, superficial femoral, or proximal popliteal arteries via transradial access. The study is planned to enroll 159 patients at approximately 15 sites across seven European countries.

The Principal Investigator of the RADIANCY study is Raphaël Coscas, MD, Professor of Vascular Surgery at Ambroise Paré Hospital in Boulogne-Billancourt near Paris, France.

“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,” commented Prof. Coscas in Cordis’ press release. He continued, “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 first procedure in the study was performed by Mercedes Guerra, MD, Chief of Angiology, Vascular and Endovascular Surgery at the University Hospital of Guadalajara, Spain.

Cordis advised that Dr. Guerra used the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal angioplasty balloon catheter to facilitate delivery of the SMART Radianz self-expanding stent in an iliac lesion.

Dr. Guerra stated in the company’s press release, “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.”

In March 2022, Cordis announced FDA approval of the SMART Radianz vascular stent system for use in the United States. On June 16, the company announced that the first-in-human procedures were performed by Jihad Mustapha, MD, Chief Executive Officer and Director of Endovascular Intervention at Advanced Cardiac & Vascular Centers for Amputation Prevention, in Grand Rapids, Michigan.