Cordis SMART Radianz Vascular Stent System Evaluated in European RADIANCY Study

November 16, 2023—Cordis announced the completion of patient enrollment in the RADIANCY premarket clinical study. Data from the RADIANCY study will be part of the clinical evidence towards pursuing the European CE Mark approval of the company’s SMART Radianz vascular stent system.

According to Cordis, the prospective, multicenter, single-arm study is designed to evaluate the safety and efficacy of the SMART Radianz vascular stent system when used with the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal angioplasty dilatation catheter for treatment of iliac and femoropopliteal artery lesions via radial artery access.

The company reported that 151 patients were enrolled at 12 sites across six countries in Europe. Patients will be evaluated through 30-day follow-up.

The results of the first 100 patients were presented at the Paris Vascular Insights course on November 9, 2023, by lead principal investigator Raphaël Coscas, MD, Professor of Vascular Surgery at Ambroise Paré Hospital in Boulogne-Billancourt, France. The final results of the study are pending.

In the company’s press release, Prof. Coscas commented, “The results are very exciting and promising with excellent technical success (97.9%) and a great safety profile. These results attest to the technological innovation and patient advantages for peripheral artery disease treatment in terms of early mobility and safety. I applaud Cordis for a successful completion of this trial and strengthening the scientific evidence for radial to peripheral procedures.”

Cordis advised that the SMART Radianz transradial vascular stent system was approved for use in the United States by the FDA in February 2022. The device received Pharmaceuticals and Medical Devices Agency approval in Japan in March 2022.