#USA #Palo Alto #Recor Medical #Paradise uRDN #Otsuka Medical Devices

Groundbreaking Clinical Results for Blood Pressure Reduction

Recor Medical, Inc. recently shared transformative clinical data regarding its innovative Paradise Ultrasound Renal Denervation (uRDN) system, highlighting the significant potential this device has in the effective management of resistant hypertension. Clinical studies released at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference indicate that patients using the Paradise system experienced an average reduction in blood pressure of 19.6 mmHg within just six months. This remarkable result sets a new standard in hypertension treatment, particularly for those who have not found relief through traditional medications or lifestyle modifications.

Study Insights from GPS Registry

The data presented confirmed that the Paradise uRDN system was part of the Global Paradise System (GPS) Registry, an extensive, prospective and retrospective study conducted across nine countries. Lead author Dr. Karl Fengler, from the Heart Center in Leipzig, shared that early analysis involved 212 patients. These individuals had significantly higher baseline blood pressures than in prior studies, marking a pivotal moment for understanding how the Paradise system can be deployed in high-risk populations.

Results showed a compelling reduction not only in office systolic blood pressure but also in home monitoring readings, with the latter showing a reduction of 14.4 mmHg. Importantly, the safety profile remained robust, with no serious safety concerns reported. This registry serves as a real-world indicator of the device’s effectiveness, providing physicians with confidence in its application for their patients.

Sustained Results over Two Years

Further underscoring the effectiveness of the Paradise system is data from the RADIANCE clinical trial program, which pooled results from three separate studies. This pooled analysis included follow-up data from 243 patients over a period of 24 months, revealing a sustained reduction in blood pressure of 15.7 mmHg. This significant finding further validates the device's potential to offer lasting relief and highlights the durability of its effects in the treatment journey of hypertension patients.

As presented by Dr. Ajay J. Kirtane, a respected professor at Columbia University, these two years of data provide a strong case for the Paradise system not only as a viable treatment option but also as a critical tool in the long-term management of hypertension. The potential to reduce cardiovascular risks associated with high blood pressure is critical in improving patient outcomes and quality of life.

Innovation at Work

The Paradise uRDN system stands out for its innovative approach, designed to reduce the overactivity of sympathetic nerves surrounding renal arteries. Utilizing ultrasound technology, this system applies 360-degree ultrasound energy to the renal nerves, which helps to lower blood pressure. Furthermore, the exclusive HydroCooling™ system used during the procedure protects renal artery walls, addressing clinician and patient concerns alike.

According to Lara Barghout, President and CEO of Recor Medical, these findings not only demonstrate the therapeutic value of the Paradise uRDN but also reinforce the company's commitment to advancing treatment for resistant hypertension. As more healthcare providers consider this technology, the potential impact on patients’ lives continues to grow.

Market Availability and Future Evidence

Since receiving FDA approval in November 2023, the Paradise system is available in the United States, with further approvals in the European Union and Japan as well. This accessibility is crucial as healthcare systems strive to address the needs of those who suffer from uncontrolled hypertension, an issue that affects millions globally.

As Recor Medical continues its mission, the company is dedicated to gathering further real-world evidence through the GPS Registry, enhancing the clinical understanding of how this technology can be utilized effectively. The thirst for more data and better results drives innovation in medical treatments, and the Paradise uRDN system represents a significant step forward.

In conclusion, the results from the Global Paradise System and RADIANCE studies provide remarkable insights into how pediatric and adult patients suffering from resistant hypertension can benefit from new technological advancements. With a commitment to ongoing research and patient safety, Recor Medical may have opened the door to a new era in hypertension management, ultimately working towards improved survival rates and enhanced patient wellbeing.