From June 29 to July 2, 2023, the 21st China Interventional Cardiology Conference (CIT2023) adopted an “online+offline” approach at the National Convention Centersmoothnessconvening.

As the largest and most influential high-quality academic conference in the field of interventional cardiology in China and the Asia-Pacific region, the CIT Conference has become an important platform for international academic exchanges between outstanding experts at home and abroad, covering all fields of interventional cardiology. In the field of renal nerve block therapy (RDN) research, the results achieved by Chinese scholars have rivaled and even led the world.

Among them,ByAcademician Gao Runlin and Professor Jiang Xiongjing of Fuwai Hospital are the main researchersoftheThe results of the Iberis-HTN clinical study are inCIT 2023 ConferenceLate Breaking and the special conference were announced for the first time.

Iberis-htnResearch Results: Efficacy and Safety Fully Verified

Iberis-HTN (NCT02901704) is a prospective, multicenter, blind, randomized controlled trial designed to evaluate IberisSafety and efficacy of a multi-electrode renal artery radiofrequency ablation catheter system in the treatment of primary hypertension. The centers participating in the study included 16 of the top three domestic hospitals, including Fuwai Hospital, West China Hospital of Sichuan University, and Ruijin Hospital affiliated to Shanghai Jiao Tong University.

Judging from the trial design, the main clinical endpoint of the IBERIS-HTN trial was the change in the average systolic blood pressure of 24 h 6 months after surgery compared to the baseline.

Secondary clinical endpoints include: changes in average diastolic pressure in dynamic blood pressure 24 hours 6 months after surgery; clinical systolic blood pressure compliance rate 6 months and 12 months after surgery; changes in clinic blood pressure 1 month, 3 months, 6 months, and 12 months after surgery; and types and doses of medication taken 1 month, 3 months, 6 months, and 12 months after surgery. A total of 217 patients were enrolled in the trial, randomly assigned 1:1 to the renal artery ablation (RDN) surgery group or sham surgery group (renal angiography only), and surgical and post-operative follow-up were carried out in strict accordance with the established clinical trial plan and random sampling results.

According to the Iberis-HTN test results, it is shown that IberisThe efficacy and safety have been fully verified in tests.

Among them,In terms of effectiveness,Compared to the baseline, use IberisRDN system patients had a reduction of 11.93 mmHg in systolic blood pressure ABPM for 24 hours 6 months after surgery, a decrease of 9.35 mmHg compared with the fake surgery group (-2.58 mmHg).There is also a statistical difference (P<0.0001).

In terms of security, Iberis-HTN testNo serious device-related adverse events were observed.

Iberis:The world's leading RDN products

The good news is,IberisAs the world's leading RDN product, its innovative product features and clinical plan design were unanimously recognized by participating experts.

in IberisIn terms of product design,Professor Chiang Xiong-jingMake it clear that:

“(1) Iberis The RDN ablation catheter uses a 4-electrode design, which can perform renal artery sympathetic ablation more efficiently;

(2) IberisThe head end of the RDN ablation catheter has an adaptive design, provides stronger radial support, and can adapt to different diameters of renal artery blood vessels, reducing the difficulty of operation while further ensuring the adhesion and ablation effects;

(3) IberisThe RDN ablation catheter matches the 6F guide tube, making it the only RDN product in the world that is compatible with both radial artery and femoral artery access. Transventricular artery RDN surgery not only complies with the current situation where more than 95% of domestic PCI surgeries are transductal intervention, but can also significantly reduce the complications of entraprectal puncture and improve patient satisfaction. At the same time, this feature also allows RDN surgery to be performed through day surgery, reducing the financial burden on patients.”

in IberisIn terms of clinical plan design,Professor Xu JianzhongIt shared the history of RDN technology development, summarized the clinical designs of many RDN products carried out around the world, and pointed out:

“Currently, most overseas RDN clinical trials use 24-hour dynamic blood pressure as the main endpoint. 24-hour dynamic blood pressure is more suitable for evaluating the efficacy of RDN. The 24-hour dynamic drop in blood pressure is more directly related to the reduction in the probability of cardiovascular events, and is less likely to be disturbed by influencing factors such as placebo effects and white coat effects.”

Furthermore,Professor Yu JingBased on actual cases from clinical trials, it was stated: “IberisIt has good adaptability and matches the 6F guide tube, which can achieve full ablation of the main stem and branch of the renal artery, which is more conducive to lowering blood pressure after surgery.”

Go abroad and lead the world

High blood pressure is a common chronic disease in our country. The patient base is huge, so there is no time to delay effective prevention and treatment. The advent of RDN is expected to open a new era in the treatment of hypertension.

Currently, the global RDN market has yet to launch its first product, and many domestic and foreign companies are vigorously carrying out product research and development. Orient Securities pointed out, “The technical barriers to RDN therapy are high, and the first companies to be approved for advanced products may occupy a large share of the market.”

Surprisingly, a number of leading local RDN companies have begun to go overseas, leading the way in innovative research and development, and have been highly recognized by overseas academics.

For example, Bai Xin An, which adheres to the original intention of “innovating and leading high-quality medical care.”

Since Antong Healthcare, a holding subsidiary of Baixin Anqi, was founded in 2011, IberisAfter nearly 12 years of intensive research and development, it shows Baixinan/Antong Medical's determination to stick to RDN products for a long time. It also brings together the hard work of Academician Gao Runlin, Professor Jiang Xiongjing, and all of the main researchers involved in the research.

2016, IberisIt has obtained EU CE certification and completed its first human clinical trial in Japan.

Currently, Baixian has initiated a post-marketing clinical RADIUS-HTN in Europe to compare the efficacy and cost effectiveness of RDN surgery performed on the radial artery and femoral artery. 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.

Notably, IberisThe advantage of being able to achieve day surgery through the lumbar artery has been highly recognized by overseas surgeons, and there are also case reports of PCI and RDN performed through a lumbar artery puncture.