China-based Bio-heart Biological Technology Co., Ltd. (HKG: 2185) and its holding subsidiary Angiocare have announced the clinical results for the Iberis-HTN trial at the China Interventional Therapeutics 2023 conference. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial designed to evaluate the safety and efficacy of the Iberis Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System in the treatment of primary hypertension (NCT02901704).
Trial Enrollment and Outcomes
A total of 217 subjects were enrolled in the trial, which demonstrated that the Renal Denervation (RDN) group achieved the primary clinical endpoint of efficacy. This endpoint was measured as the change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure monitoring at 6 months after the procedure. The RDN group showed a significant superiority over the sham control group. Specifically, the 24-hour systolic ABPM for the RDN group was reduced by 11.93 mmHg compared to baseline, while the sham group experienced a reduction of 2.58 mmHg. The net change between the groups was a 9.35 mmHg reduction, which was statistically significant (P<0.0001). No device-related major adverse events were observed during the trial.
Regulatory Milestones and Unique Features of Iberis
Iberis, a catheter-based procedure for the treatment of hypertension, is awaiting regulatory decisions in China. The system received the CE mark in the European Union (EU) in 2016 and concluded its first-in-human study in China. It is currently the only RDN system globally with CE marking that can be used for both the transradial approach (TRA) and transfemoral approach (TFA), highlighting its versatility and innovation in the field of hypertension treatment.-Fineline Info & Tech
