#USA #Palo Alto #Hypertension #Paradise System #Recor Medical

Significant Advancements in Hypertension Treatment

Recent clinical data from the Global Paradise System registry has revealed promising results regarding the efficiency of Recor Medical’s ultrasound renal denervation system, known as Paradise. Presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference, this study showcased not only the immediate benefits but also the long-term effects of the treatment on patients suffering from resistant hypertension.

Details from the Global Paradise System Registry

This latest registry data indicates a substantial average reduction of 19.6 mmHg in systolic blood pressure, measured in clinical settings, at the six-month follow-up mark after the application of the Paradise system. This registry is defined as a mix of prospective and retrospective studies conducted across nine countries outside the U.S., aiming to assess the efficacy and safety of the ultrasound renal denervation (uRDN) treatment. Over the course of the study, 212 patients were analyzed prospectively, and the findings suggested statistical significance (p<0.0001) in the reduction figures.

Moreover, patients exhibited a 14.4 mmHg decrease in home-measured systolic blood pressure, further reinforcing the treatment's effectiveness. The procedure not only showed significant results but also improved in efficiency compared to earlier RADIANCE trials, with reduced procedural times and less contrast volume being utilized. Safety concerns were noted to be minimal, allowing for a broader acceptance of the treatment protocol.

Long-Term Efficacy from the RADIANCE Studies

The outcomes through the analysis of the RADIANCE clinical trials further strengthened the evidence of long-term treatment benefits. In this aggregation of results, 243 patients who were randomized across three studies experienced an average decrease of 15.7 mmHg in systolic blood pressure at the 24-month follow-up. The enduring effects of the treatment emphasize the system's capability of maintaining reduced blood pressure over time.

Lara Barghout, President and CEO of Recor Medical, stated, “The accumulating clinical evidence from real-world scenarios continues to demonstrate the efficacy of the uRDN Paradise system in significantly lowering blood pressure in patients dealing with uncontrolled and resistant hypertension.” This highlights not just the effectiveness of the treatment but also its safety as a long-term hypertension management solution.

Helen Reeve-Stoffer, the Chief Medical Officer of Recor Medical, further elaborated on the clinical implications of these findings, describing the potential for significant cardiovascular risk reduction correlated with the observed drops in blood pressure. She reinforced confidence in the consistency and safety of obtaining such results across different patient groups.

The Technology Behind the Paradise System

The ultrasound renal denervation technology works by targeting and ablating the sympathetic nerves surrounding the renal arteries, effectively diminishing their overactivity which is often the cause of hypertension. The procedure involves administering either two or three short bursts of ultrasound energy directed at the renal arteries, while simultaneously utilizing an exclusive HydroCooling™ system that protects arterial walls during the treatment.

Since its FDA approval in November 2023, the Paradise system has been hailed as a transformative option for patients who have not achieved adequate blood pressure control through lifestyle modifications or medications. Common adverse events relate to access site complications and mild discomfort, but serious safety issues have been notably absent in the treatment cohort.

Conclusion

Recor Medical's ongoing commitment to providing innovative solutions for managing hypertension marks a new era for patients. The significant drops in blood pressure recorded within the Global Paradise System and RADIANCE studies not only affirm the system's effectiveness, but they also underscore its transformative potential in enhancing patient quality of life, thereby making it a cornerstone in treating resistant hypertension globally. Continued research and evidence generation will be critical as Recor Medical advances its mission in hypertension therapy improvement.