Cordis Announces Enrollment Completion of the RADIANCY Clinical Study in Europe
By Azmed Devices Editorial Team
Cordis has successfully completed patient enrollment for the RADIANCY clinical study, which evaluates the safety and efficacy of its radial-access vascular stent system in European patients.
According to Cordis, the company has finished patient enrollment for the RADIANCY Pre-market Clinical Study, a prospective, multi-center, single-arm trial focused on evaluating the S.M.A.R.T. RADIANZ Vascular Stent System. When used in conjunction with the BRITE TIP RADIANZ Guiding Sheath and SABERX RADIANZ PTA Dilatation Catheter, the system is designed to treat iliac and femoropopliteal artery lesions through radial artery access. The data collected from this study is intended to support the pursuit of the CE Mark for the vascular stent system.
The study reached a total of 151 subjects across 12 different European sites. Preliminary results for the first 100 participants were shared at the Paris Vascular Insights event in November 2023. Lead investigator Professor Raphaël Coscas reported a 97.9% technical success rate, highlighting the safety profile and potential for improved patient mobility during peripheral artery disease treatment. Cordis notes that the final results of the study are currently pending further review.
Cordis leadership emphasizes that the transradial approach offers significant clinical benefits, including reduced risks of complications like bleeding or infection, greater patient comfort, and faster recovery times. By expanding the use of the Radianz Radial Peripheral System, the company aims to extend these advantages to peripheral interventions. The S.M.A.R.T. RADIANZ Vascular Stent System has previously received regulatory approvals in the United States and Japan.
Source
This article summarizes an official Cordis announcement. Read the original at https://cordis.com/emea/news/cordis-announces-enrollment-completion-of-the-radiancy-clinical-study-in-europe. Product availability in Azerbaijan is subject to local registration; contact Azmed Devices for current status.
