Paradise uRDN System Demonstrates 19.5 mmHg Blood Pressure Reduction at 12 Months, with Durability Through 4 Years

Seven abstracts sponsored by Recor Medical presented at TCT 2026 highlight expanding clinical evidence for ultrasound renal denervation.

Palo Alto, CA, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Recor Medical, Inc. (“Recor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., today announced the latest results from its Global Paradise System (GPS) Registry, demonstrating significant blood pressure reductions in patients treated with the Paradise™ Ultrasound Renal Denervation (uRDN) system. The GPS Registry findings were presented as part of the Best of Endovascular Abstracts at the 2026 Transcatheter Cardiovascular Therapeutics (TCT) conference. A total of seven Recor-sponsored abstracts were presented, including US real-world data and 4-year durability data, further expanding the body of clinical evidence supporting the Paradise uRDN system.

Global Real-World Results
In the abstract Blood Pressure Outcomes Following Ultrasound Renal Denervation in Uncontrolled Hypertension: 12-Month Results from the Global Paradise System Registry, Prof. Felix Mahfoud, MD, presented findings from 276 patients treated across nine European countries. At 12 months, patients experienced 19.5 mmHg reduction in office systolic blood pressure, with a greater reduction of 22.0 mmHg among those with a history of hypertensive crisis. Half achieved a reduction of at least 15.0 mmHg. Favorable procedural and clinical safety were observed.

“The 12-month GPS Registry results provide compelling real-world evidence supporting the safety and effectiveness of the Paradise uRDN system,” said Co-Principal Investigator Prof. Felix Mahfoud, MD, University Hospital Basel. “The magnitude of blood pressure reduction observed in routine clinical practice is clinically meaningful, including among patients with a history of hypertensive crisis, a population with substantial unmet need.”

Additional real-world results were presented by Behnam N. Tehrani, MD in Sustained Blood Pressure Reduction, High Clinical Success, and Favorable Safety Following Ultrasound Renal Denervation: A Multicenter US Experience. In 238 pooled patients treated with the Paradise uRDN system, favorable safety and procedural outcomes were observed. Office systolic blood pressure was reduced by 26.9 mmHg at 12 months among 58 patients with complete longitudinal follow-up.

4-Year Durability from RADIANCE Pooled Analysis
In Durable Blood Pressure Reduction Through 4 Years Following Ultrasound Renal Denervation: Pooled Data from the RADIANCE Trial Program, Co-Principal Investigator Prof. Ajay J. Kirtane, MD, presented outcomes from 293 uRDN patients treated across RADIANCE-HTN SOLO and RADIANCE II (mild to moderate hypertension) and RADIANCE-HTN TRIO (uncontrolled, resistant hypertension). At 4 years, office systolic blood pressure was reduced by 14.9 mmHg, and 92% of patients demonstrated either a reduction in blood pressure or decreased antihypertensive medication use following treatment with the Paradise uRDN system. No new long-term safety concerns were observed.

“Many patients and clinicians have asked about the longer-term results following a renal denervation procedure, and in this light it is very encouraging to report sustained blood pressure reductions out to 4 years after uRDN,” said Prof. Ajay J. Kirtane, MD, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons. Note: Prof. Kirtane reports Institutional funding to Columbia University from Recor Medical.

“The evidence for uRDN has never been stronger. Across randomized clinical trials and real-world practice, we are seeing meaningful and durable blood pressure reductions across a broad range of patients with uncontrolled hypertension,” said Shon Chakrabarti, MD, Chief Medical Officer of Recor Medical. “These findings reinforce our confidence in the Paradise uRDN system and, importantly, underscore the potential for renal denervation to change the treatment paradigm for a disease that remains one of the most significant challenges in cardiovascular medicine.”

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.

Named one of the Best Inventions of 2026 by TIME^*, the Paradise uRDN system is currently commercially available 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.

*From TIME ©2026 TIME USA LLC. All rights reserved.  Used under license.

About Recor Medical, Inc.
Recor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. headquartered in Palo Alto, Calif., is a medical technology company dedicated to transforming the management of treatment resistant hypertension through the Paradise™ Ultrasound Renal Denervation (uRDN) system. The Paradise uRDN system is FDA approved for sale in the United States, CE 2797 marked and approved in markets where the CE 2797 mark is accepted, per approved indications for use, and received regulatory approval in Japan. 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/

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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• About the Paradise uRDN System

Helen Reeve-Stoffer
Recor Medical
+1 650 542 7700
hreeve-stoffer@recormedical.com