Core Viewpoint - The article highlights a significant clinical breakthrough in hypertension intervention at the Ospedale San Pietro FBF Roma, where the Iberis® RDN system was successfully used for the first time in two cases of renal denervation (RDN) via transradial access (TRA) [3][4]. Group 1: Clinical Breakthrough - The successful application of the Iberis® RDN system marks a new phase in minimally invasive and effective hypertension treatment in Italy [4]. - The procedures were led by experienced doctors Dario Bertolone and Roberta Serdoz, with guidance from Professor Francesco Monti and Professor Francesco Rotolo [3]. Group 2: Case Details - **Case 1**: A 49-year-old female patient with medication adherence issues underwent RDN treatment using the Iberis® system via left TRA. The procedure involved 6 and 8 ablations on the left and right renal arteries, respectively, and 1 ablation on the left accessory renal artery [6]. - **Case 2**: A 73-year-old male patient with poor control on four antihypertensive medications also received treatment via left TRA. The procedure included 8 and 7 ablations on the left and right renal arteries, respectively, and 2 ablations on the right accessory renal artery [9]. Group 3: Advantages of the Iberis® System - The Iberis® system demonstrated strong radial support, stable vascular wall adherence, and excellent maneuverability during the TRA procedures, offering a new, less invasive option compared to traditional femoral access [6]. - The emphasis on the importance of ablating accessory renal arteries was highlighted, as it contributes to more comprehensive renal nerve modulation, leading to better and longer-lasting blood pressure control [9]. Group 4: Future Implications - The successful implementation of the Iberis® RDN system in these cases provides a solid foundation for the clinical promotion of individualized and minimally invasive hypertension intervention strategies [9]. - Ongoing follow-up data is anticipated to further evaluate the long-term efficacy and safety of the Iberis® system, with the company committed to advancing RDN technology both domestically and internationally [9].

Core Viewpoint - The successful application of the Iberis® RDN system in a high-risk patient with resistant hypertension and chronic kidney disease (CKD) demonstrates a new treatment pathway and clinical evidence for blood pressure control and renal protection [2][3][15] Indications and Treatment Objectives - The case targets patients whose blood pressure remains uncontrolled despite multiple antihypertensive medications and who are at risk of further renal function deterioration. The goal is to explore the feasibility and potential clinical value of radiofrequency renal denervation (RDN) in achieving precise and sustained blood pressure reduction while delaying the progression of renal damage [5][6] Technical Advantages of Radial Access - The use of radial artery access for RDN offers multiple advantages over traditional femoral access, including better patient tolerance, lower risk of puncture site complications, and effective navigation of vascular challenges such as tortuous or narrowed arteries. This successful application expands the options for RDN procedures in high-risk populations [8] Technical Features of Iberis® RDN System - The Iberis® RDN system features a multi-electrode ring-shaped ablation design that ensures good vascular wall adherence and stability, allowing for more uniform energy distribution around the renal artery. This design reduces the risk of thermal damage to surrounding tissues and enhances the safety and efficacy of RDN procedures [10] Evidence Basis: GSR-DEFINE Study Data Support - The clinical practice and efficacy assessment of this case are supported by robust evidence from the global SYMPLICITY registry GSR-DEFINE, which analyzed over 3,500 patients with resistant hypertension, including those with moderate to severe CKD. The study showed an average reduction in office systolic blood pressure of approximately 12-17 mmHg across different CKD groups after three years of follow-up, indicating sustained and clinically significant blood pressure control [12][13] Clinical Significance and Future Outlook - The successful use of the Iberis® RDN system via radial access in patients with resistant hypertension and CKD reaffirms the clinical potential of RDN in high-risk populations. With strict adherence to indications and close follow-up, RDN is not only an effective tool for blood pressure control but also holds promise for renal protection in patients with impaired kidney function. As a key complement to the "blood pressure reduction + target organ protection" strategy, Iberis® RDN will continue to provide long-term, sustainable, and precise treatment options for high-risk patients with resistant hypertension and renal impairment [15]

Core Viewpoint - The RDN (Renal Denervation) market is on the verge of explosive growth, driven by new guidelines and reimbursement decisions in the U.S. that include RDN as a treatment for resistant hypertension, indicating a significant commercial opportunity for the sector [3][4]. Group 1: Market Potential and Growth - The RDN market is projected to grow at a compound annual growth rate (CAGR) of 22% from 2023 to 2028, making it one of the fastest-growing segments in the medical device field [3]. - The long-term market potential for RDN in China is expected to exceed 10 billion yuan [3]. Group 2: Technological Developments - Recent FDA approvals for RDN products from Recor Medical and Medtronic mark a turning point for the technology, providing differentiated options in ultrasound and radiofrequency ablation [4]. - The introduction of the Iberis® RDN system by Bai Xin An, which is the only device approved for both transradial and transfemoral access, represents a significant innovation in the RDN space [5][6]. Group 3: Competitive Landscape - Chinese companies like Xinmai Medical, Meili Weiye, and Antong Medical have received approvals for their RDN products, showcasing the innovative capabilities of domestic firms [5]. - Blue Sail Medical, through its subsidiary Blue Sail Bosheng, has established a comprehensive international sales network, covering over 8,000 hospitals in more than 100 countries, positioning itself as a key player in the global market [6][10]. Group 4: International Expansion - The Iberis® RDN system has already seen successful clinical applications in various provinces in China and has completed its first commercial procedure in Europe [8]. - Collaborations between Chinese companies and international partners, such as Bai Xin An and Blue Sail Medical, are facilitating the entry of RDN products into overseas markets, with significant progress in countries like Germany, Spain, and Italy [9][11]. Group 5: Future Outlook - The RDN technology is set to lead a new era in hypertension treatment, with a vast unmet clinical need indicating substantial future market potential [11]. - Continuous innovation and international clinical collaborations are expected to enhance the global presence of Chinese RDN products, allowing them to capture a significant share of the high-end medical device market [11].