Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced that its Iberis multi-electrode renal radiofrequency denervation (RDN) system has successfully reached its primary clinical endpoint in the randomized, controlled Iberis-HTN study for the treatment of primary hypertension.
Iberis-HTN Study Results
The prospective, multicenter, blinded, randomized controlled trial was designed to assess the safety and efficacy of the Iberis system in primary hypertension. The study demonstrated that patients who received RDN surgery using the second-generation Iberis experienced significantly better mean systolic blood pressure changes during the 6-month 24-hour ambulatory blood pressure monitoring period compared to the baseline. This improvement was observed in conjunction with similar safety profiles and no increased risk of adverse events when compared to the placebo surgery group.
Advantages of the Second-Generation Iberis System
The second-generation multi-electrode Iberis system offers significant advantages over single-electrode RDN products under development. It can effectively reduce surgical time and minimize the risk of radiation exposure for both patients and medical professionals. Additionally, compared to products that can only ablate the main renal artery, the second-generation Iberis system can enhance the blood pressure-lowering effects of renal nerve blockade surgery.
Recognition and Approval Status
The Iberis system was awarded “innovative medical device” status by the National Medical Products Administration (NMPA) in November 2016, making it eligible for fast-track approval. This recognition underscores the potential impact of the Iberis system on the treatment of primary hypertension and its commitment to innovation in medical device technology.-Fineline Info & Tech
