China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced the first patient enrollment in the RADIUS-HTN study for its Iberis renal radiofrequency denervation (RDN) system, marking a significant milestone in Bordeaux, France.
Objectives and Design of the RADIUS-HTN Study
The RADIUS-HTN study is designed to assess the performance of the second-generation Iberis RDN system in treating uncontrolled hypertension. The trial will compare the efficacy of renal nerve blockade through two different access methods: trans-radial access (TRA) and trans-femoral access (TFA). This comparison aims to evaluate the effectiveness of the Iberis RDN system in a minimally invasive surgical approach to hypertension treatment.
Iberis RDN System and Partnership with Terumo Corporation
The Iberis RDN system is a device that enables minimally invasive surgery for the treatment of hypertension. It is being jointly developed by Shanghai Bio-Heart and its partner, Terumo Corporation. This collaboration combines the expertise of both companies to advance the development and clinical application of the Iberis RDN system.
Implications for Hypertension Treatment
The initiation of the RADIUS-HTN study and the enrollment of the first patient signify a step forward in the clinical evaluation of the Iberis RDN system. The study’s findings could potentially influence the future treatment paradigms for uncontrolled hypertension, offering a new option for patients and healthcare providers.-Fineline Info & Tech
