Shanghai2023/6/30 /PRNewswire/ -- Baixinan (02185.HK) and its holding subsidiary Antong Healthcare announced the clinical results of Iberis HTN at the 21st China Interventional Cardiology Conference (CIT 2023) in 2023. Iberis HTN (NCT02901704) is a prospective, multicenter, blind, randomized controlled trial to evaluate the safety and efficacy of the Iberis multi-electrode renal artery radiofrequency ablation catheter system for primary hypertension. The study was led by Academician Gao Runlin and Professor Jiang Xiongjing of Fuwai Hospital. A total of 217 test subjects were included in the group. The results showed that the renal artery ablation (RDN) group achieved the main clinical endpoint of efficacy (change in average systolic pressure compared to baseline during dynamic blood pressure 6 months and 24 hours after surgery) and was significantly superior to the sham surgical group. Compared with the baseline, the 24-hour systolic ABPM of the RDN group decreased by 11.93 mmHg, and the sham surgery group reduced by 2.58 mmHg. The difference in blood pressure reduction between the RDN group and the control group was 9.35 mmHg, which is statistically significant (P<0.0001). No serious device-related adverse events were observed. The efficacy and safety of Iberis were verified in trials.
About Iberis:
Iberis is an innovative minimally invasive surgical device used to treat high blood pressure. Iberis has applied for registration in China, obtained CE certification in the European Union in 2016, and completed its first human clinical trial in Japan. Iberis is currently the only CE-marked compatible radial artery access (TRA) and femoral artery access (TFA) RDN system in the world. The radial artery access route is the first choice for interventional physicians because it has fewer complications, shorter hospital stays, and lower overall cost of surgery. Patients also acknowledge the benefits of surgery through a radial artery access route. The radial artery access allows RDN to be performed by day surgery. Iberis can match the 6F guide tube to achieve complete ablation of the main trunk and branch of the renal artery, so as to obtain better curative effects. Baixian has initiated a post-marketing clinical RADIUS-HTN in Europe to compare the efficacy of radial artery and femoral artery RDN surgery. The main researcher at RADIUS-htn is Professor Felix Mahfoud from Saarland University Hospital, Homburg/Saar, who is also the chairman of the Arterial Hypertension Working Group of the German Society of Cardiology.
About Baixinan:
Shanghai Baixinan Biotechnology Co., Ltd. is a leading cardiovascular innovative medical device company headquartered in China Radiation Global. Baixinan's mission is to “innovate and lead high-quality medical care”. Baixian focuses on biodegradable stents (BRS), renal artery ablation (RDN), and drug-coated balloons (DCB) to meet unmet clinical needs.