Latest Real-World Clinical Data Demonstrate a 19.6 mmHg Reduction in Blood Pressure at 6 months with Recor Medical's Paradise Ultrasound Renal Denervation System
Data Presented at the 2025 TCT Conference from the Real-World Global Paradise System Registry Show a Significant and Meaningful BP Reduction at 6 Months, and a Pooled Data Analysis from the RADIANCE Clinical Trial Program Demonstrates a 15.7 mmHg Sustained Blood Pressure Reduction at Two Years.
PALO ALTO, Calif. and FRANKFURT, Germany, Nov. 3, 2025 /PRNewswire/ -- Recor Medical, Inc. ("Recor") and its parent company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices"), announced results from two clinical studies presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference : data from the Global Paradise System (GPS) Registry demonstrated a 19.6 mmHg reduction in office systolic blood pressure at six months with the Paradise™ Ultrasound Renal Denervation (uRDN) system; and the pooled analysis of data from the RADIANCE global clinical trial program showed a sustained reduction of 15.7 mmHg in office systolic blood pressure at 24 months. The Paradise uRDN system is a device-based adjunctive therapy for patients with uncontrolled and resistant hypertension whose blood pressure cannot be properly managed with lifestyle changes and medication.
19.6 mmHg BP Reduction in 6-Month Data from the GPS Registry
The GPS Registry is a real world, all comers, prospective and retrospective registry being conducted in nine countries outside of the United States, designed to assess the long-term safety and effectiveness of the Paradise uRDN system when used according to its labeling. Presented by Dr. Karl Fengler, Heart Center, Leipzig, the results included the first prospective analysis of data from 212 patients. Office systolic blood pressure at 6 months post-procedure was reduced by 19.6 mmHg and home systolic blood pressure was reduced by 14.4 mmHg compared to baseline (all p<0.0001). Procedure times, contrast volume, and fluoroscopy time were all reduced compared to the previous RADIANCE trials. This cohort of patients represents a higher risk profile and higher baseline blood pressures than previous RADIANCE studies. No safety concerns were observed.
15.7 mmHg BP Reduction in RADIANCE Pooled Analysis at Two Years
The RADIANCE Pooled Analysis includes data collected through 24 months follow-up from 243 patients randomized in the three studies from Recor's RADIANCE Global Program: RADIANCE-HTN TRIO, which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mild-moderate hypertension. Presented by Ajay J. Kirtane, MD, Professor of Medicine at Columbia University, Irving Medical Center, data from a pooled cohort of patients from the RADIANCE trials showed a reduction of 15.7 mmHg in office systolic blood pressure at 24 months, demonstrating that the blood pressure reductions are sustained at the two-year follow-up. No safety concerns were observed.
"The growing body of real-world evidence continues to demonstrate the power of the Paradise uRDN system to meaningfully lower blood pressure in patients with uncontrolled and resistant hypertension," said Lara Barghout, President and CEO of Recor Medical. "These results further strengthen the case for the Paradise uRDN system as a safe, durable, and effective treatment option and underscore the important and real impact this therapy can have on patients' lives."
"The magnitude of reduction demonstrated in the GPS Registry data and the sustained results shown in the RADIANCE pooled analysis are clinically meaningful," said Helen Reeve-Stoffer, Chief Clinical Officer of Recor Medical. "The level of blood pressure reduction seen in the GPS Registry may translate into a marked decrease in cardiovascular risk for patients, and the data provide confidence for physicians in the continuity of the blood pressure reduction. The consistency of results observed across our clinical trials and real-world data reinforces the robust therapeutic value and safety of the Paradise uRDN system. We look forward to continuing to collect more real-world and long-term data."
The Paradise uRDN system is currently commercially available for patients in the U.S. having received FDA approval in November 2023. The Paradise Ultrasound Renal Denervation system (Paradise system) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure. Potential procedure-related adverse events including pain, vascular access site complications, and vasospasm are most common. Individual results may vary.
About the Paradise uRDN System
The Paradise uRDN system is a novel ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise uRDN system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
About Recor Medical, Inc.
Recor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. headquartered in Palo Alto, USA, is a medical technology company dedicated to transforming the management of treatment resistant hypertension through the Paradise™ Ultrasound Renal Denervation (uRDN). The Paradise uRDN system is FDA approved for sale in the United States, CE marked and approved in markets where the CE mark is accepted, and authorized for marketing and manufacturing in Japan, per approved indications for use. Clinical evidence for the Paradise uRDN system includes positive outcomes in three independent, randomized, sham-controlled studies in patients with mild-to-moderate and resistant hypertension. In addition, Recor is advancing real-world evidence generation through the Global Paradise System ("GPS") Registry in the European Union and the UK, as well as the US GPS post-approval study in the United States.
http://www.recormedical.com/ ; http://www.recormedical.eu
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices Co., Ltd. engages in the global development and commercialization of medical devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578). https://www.omd.otsuka.com/en/
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