Golden Leaf Med Tec's Renal Denervation System: The Only Domestic and One of Only Two Global RF-Based Platforms Granted FDA Breakthrough Device Designation

Shanghai Golden Leaf Med Tec Co., Ltd.’s independently developed renal denervation (RDN) system for the treatment of hypertension has been granted “Breakthrough Device Designation” by the U.S. FDA. Based on radiofrequency energy, the product features a globally unique six-electrode basket-shaped design that enables efficient ablation of sympathetic nerves surrounding the renal arteries, thereby achieving minimally invasive interventional treatment for hypertension.

Hypertension is the single largest risk factor for mortality worldwide. For every 10 mmHg increase in systolic blood pressure, the risk of stroke and fatal myocardial infarction increases by 53% and 31%, respectively, among Asian populations. China has 240 million patients with hypertension. Pharmacological therapy remains the primary treatment modality; however, poor medication adherence affects 40% of patients, resulting in a suboptimal disease control rate of only 16.8%. Additionally, approximately 18 million individuals suffer from hypertension comorbid with chronic kidney disease (CKD) and are unable to manage their blood pressure through medication alone, thereby accelerating progression toward end-stage renal disease requiring dialysis. Nearly 40 million patients in China have drug-resistant hypertension, which remains uncontrolled despite the use of multiple antihypertensive agents. If left inadequately managed, drug-resistant hypertension carries a 25% mortality rate due to complications. In this context, renal denervation (RDN) has emerged as a novel therapeutic option for hypertension management.

To date, four companies’ renal denervation (RDN) products have received the U.S. FDA “Breakthrough Device” designation worldwide: Medtronic’s Symplicity Spyral, Sonivie’s TIVUS, ReCor Medical’s Paradise, and BRATTEA’s basket-shaped six-electrode system. Among these, only Medtronic and BRATTEA employ radiofrequency-based RDN technology.

BRATTEA’s system has received this recognition due to its independent innovation in renal denervation (RDN) products and the significant clinical benefits it delivers. The system treats uncontrolled primary hypertension by performing radiofrequency ablation of the renal sympathetic nerves via a minimally invasive interventional approach. Featuring a proprietary basket-like structure, the system offers excellent conformability and superior vessel wall apposition. Its six electrodes are arranged in a 360-degree spiral pattern to ensure comprehensive coverage and efficient ablation, making it the option with the shortest procedural time among similar products and earning high acclaim from clinical centers.

BRATTEA’s system received special approval from the National Medical Products Administration (NMPA) for innovative medical devices as early as December 2019 and obtained CE certification in 2020. Its recent designation as a “Breakthrough Device” by the U.S. Food and Drug Administration (FDA) underscores the global innovativeness and leading edge of its technology. It is believed that once the product gains regulatory approval and enters the market, its commercial value will become even more apparent.