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Tigermed-Jyton Supports the Approval of Brattea's Innovative RDN System

On August 6th, Shanghai Golden Leaf Med Tech (Brattea) announced that its independently developed Netrod™ renal denervation (RDN) system：Netrod™ Six-Electrode Basket Radiofrequency Renal Denervation Catheter and Netrod™ Renal Denervation Radiofrequency Generator (including a disposable mesh renal artery radiofrequency ablation catheter and renal artery radiofrequency ablation generator) has been approved for market release by the NMPA (NMPA Registration No. 20243011385 and 20243011387). Tigermed-Jyton provided clinical trial services for this product.

Breakthrough RDN Technology: A New Treatment Option with Higher Efficacy for Hypertension

Brattea's independently developed Netrod® StarBand™ system, which Brattea holds independent intellectual property rights, consists of a renal artery radiofrequency ablation generator (including the main unit, footswitch, main unit connection cable, neutral electrode connection cable, and power cable) and a disposable mesh renal artery radiofrequency ablation catheter. These two components are used together for percutaneous renal artery radiofrequency ablation to remove renal sympathetic nerves. The disposable mesh renal artery radiofrequency ablation catheter features six electrodes arranged in a spiral pattern, significantly improving ablation efficiency. Its mesh basket design prevents blood flow blockage during ablation, making it unique both within China and internationally. The Netrod® StarBand™ system offers several advantages for RDN procedures in treating hypertension, including high safety, continuous blood pressure reduction, improved patient compliance, and a short learning curve. As an original Chinese medical device solution for treating hypertension, the Netrod® StarBand™ system addresses multiple clinical challenges, offering a revolutionary new treatment option with higher efficacy for hypertension patients.

Professional CRO Services and Optimized Solutions: A Collaborative Effort with an Innovative Medical Device Company

The clinical trial design of the Netrod-HTN study was meticulously crafted, combining innovative ideas of double-blind medical device surgical procedures with the rigorous consideration of drug compliance calculations. The complexity and challenges of executing this trial were substantial, especially given the dual pressures of the ongoing global pandemic and significant changes in medical industry regulations. Despite these obstacles, Tigermed-Jyton and the sponsor worked side by side, with both clinical teams closely collaborating to overcome difficulties and steadily advance the project.

Throughout the execution of the project, the Tigermed-Jyton’s clinical team continuously optimized management processes and strengthened communication. The successful enrollment of each participant was a testament to the team’s wisdom and collaborative spirit. Through relentless exploration and innovation, the team developed a practical and efficient implementation strategy, ensuring the smooth progress of the project.

The project spanned 25 clinical centers nationwide, with a large and geographically dispersed team. This required the Tigermed-Jyton’s clinical team to meticulously plan strategies and invest significant time and effort into execution, enhancing seamless collaboration across the team to ensure project continuity and stability. Particularly during patient follow-up, the team faced dual challenges of drug distribution management and data collection due to the frequent follow-up points and the complex environment of pandemic lockdowns. In response, the Tigermed-Jyton's clinical team quickly established an efficient project management system. The team members demonstrated a high level of responsibility and meticulous attention to detail, effectively overcoming these challenges.

It was this unwavering determination and pioneering spirit, driven by the commitment to patient health, that allowed Tigermed-Jyton and Brattea to work together efficiently and effectively, successfully completing the clinical trial. Ultimately, they witnessed the successful approval and market release of the Netrod® StarBand™ mesh renal artery radiofrequency ablation system, bringing a revolutionary new treatment option to the field of hypertension and benefiting a wide range of patients.

About Brattea

Founded in 2013, Brattea, based in Shanghai, integrates R&D, production, and sales, focusing on the field of minimally invasive interventional therapy as a high-tech innovative medical device company with independent intellectual property rights. The company is advancing into multiple chronic disease areas, such as diabetes, chronic obstructive pulmonary disease (COPD), and heart failure, using minimally invasive techniques to address the challenges of ineffective drug treatments, poor patient compliance, and suboptimal outcomes, thereby improving treatment success rates and reducing mortality and disability rates.