Study: Recor Medical’s Ultrasound Renal Denervation System Helps Lower Blood Pressure

Recor Medical Inc. (Recor) is reporting positive results from two clinical studies supporting the therapeutic properties of its Paradise Ultrasound Renal Denervation (uRDN) system.

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 system; and pooled data from the RADIANCE global clinical trial program indicated a sustained 15.7 mmHg reduction 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

The GPS Registry is a real world all comers, prospective, and retrospective registry being conducted in nine countries outside of the United States; it is designed to assess the Paradise uRDN system’s long-term safety and effectiveness when used according to its labeling. Results included the first prospective data analysis from 212 patients. Office systolic blood pressure at six 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 patient cohort represents a higher risk profile and higher baseline blood pressures than previous RADIANCE studies. 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,” Recor Medical President/CEO Lara Barghout sated. “These results further strengthen the case for the Paradise uRDN system as a safe, durable, effective treatment option and underscore the important and real impact this therapy can have on patients’ lives.”

15.7 mmHg BP Reduction

The RADIANCE Pooled Analysis includes data collected through 24 months follow-up from 243 patients randomized in 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. Data from a pooled cohort of RADIANCE trial patients showed a 15.7 mmHg reduction in office systolic blood pressure at 24 months, indicating the blood pressure reductions are sustained at the two-year follow-up. No safety concerns were observed.

“The magnitude of reduction demonstrated in the GPS Registry data and the sustained results shown in the RADIANCE pooled analysis are clinically meaningful,” Recor Medical Chief Clinical Officer Helen Reeve-Stoffer said. “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 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 U.S. patients, having received U.S. Food and Drug Administration approval in November 2023. The Paradise uRDN 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.

The Paradise uRDN system is an 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. 

Recor Medical Inc., a wholly owned subsidiary of Otsuka Medical Devices Co. Ltd. is a medical technology company transforming the management of treatment-resistant hypertension through the Paradise uRDN system. The is approved by the FDA, CE marked, 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 United Kingdom, as well as the US GPS post-approval study in the United States.

Otsuka Medical Devices Co. Ltd. develops and commercializes 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., a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).