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Recor Medical's Paradise System: A Breakthrough in Hypertension Management

Recor Medical, Inc., a subsidiary of Otsuka Medical Devices, has recently made waves in the medical community with the results from two pivotal clinical studies surrounding its novel Paradise™ Ultrasound Renal Denervation (uRDN) System. Presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference, the findings reveal a substantial average reduction of 19.6 mmHg in office systolic blood pressure at six months post-treatment, showcasing the system's potential in controlling resistant hypertension— a condition that affects many individuals failing to achieve satisfactory blood pressure control through traditional medication and lifestyle changes.

The Global Paradise System (GPS) Registry, which encompasses prospective and retrospective data from 212 patients across nine countries, underlines the promising performance of the Paradise system. Dr. Karl Fengler from the Heart Center, Leipzig, led the presentation, stating that alongside the noted reduction in office measurements, substantial home blood pressure reductions of 14.4 mmHg were also recorded. Notably, these results were achieved without significant safety concerns, such as procedural complications or heightened risks during treatments, essential for a procedure designed for patients with complex medical profiles.

In addition to the initial GPS findings, the second part of the presentation focused on the RADIANCE clinical trial program. Here, the pooled analysis revealed a sustained decrease of 15.7 mmHg in office systolic blood pressure after two years, further enhancing the credibility of the Paradise system as a durable option for blood pressure management. Dr. Ajay J. Kirtane, a Professor of Medicine at Columbia University, emphasized that the consistency in results across diverse trials reflects the robust therapeutic value offered by this innovative technology.

Lara Barghout, President and CEO of Recor Medical, commented on the continuously growing body of real-world evidence, asserting that the results firmly establish Paradise uRDN as a reliable and effective treatment alternative for patients facing uncontrolled hypertension challenges. Both Barghout and Chief Clinical Officer Helen Reeve-Stoffer underscored the potential of this therapy to significantly mitigate cardiovascular risk, thereby potentially leading to improved quality of life for patients.

The Paradise uRDN system utilizes cutting-edge ultrasound technology to eliminate sympathetic nerve activity in the renal arteries, addressing the root causes of hypertension. By delivering precise doses of ultrasound energy around the renal arteries, the system effectively disrupts abnormal nerve signaling linked to high blood pressure. Its HydroCooling™ system enhances safety by protecting the arterial walls during the procedure, an essential feature for minimizing adverse events typically seen with vascular interventions.

Currently, the Paradise uRDN system awaits further validation through ongoing studies, including continued data collection from both the UK and U.S. GPS post-approval studies. With recent FDA approval in November 2023, the system's commercial availability reinforces its urgent significance in the hypertensive patient community, many of whom grapple with the inadequacies of existing treatment pathways.

Recor Medical's focus on addressing the unmet needs of patients with resistant hypertension resonates deeply. The results presented reflect not only an advancement in hypertension treatment options but also signify hope for countless individuals navigating the complexities of managing their condition. By equipping healthcare professionals with effective tools and robust data, Recor Medical aims to change how hypertension is understood and treated, ultimately enhancing patient outcomes. This commitment aligns seamlessly with Otsuka Medical Devices' mission to develop innovative solutions that address persistent medical challenges.

For more information on Recor Medical's groundbreaking technology and ongoing research initiatives, interested parties can visit Recor Medical's website. Furthermore, continued updates on R&D and clinical outcomes will be pivotal in tracking the impact of the Paradise system in real-world applications moving forward.