Recor Medical Announces Positive Results from Six-Month Pooled Analysis of Data from the RADIANCE Global Clinical Trial Program at TCT 2023

Analysis shows a maintained blood pressure lowering effect with fewer added medications following treatment with the Paradise Ultrasound Renal Denervation system

Excerpt from the Press Release:

PALO ALTO, Calif.–(BUSINESS WIRE)–Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month follow-up data from the three RADIANCE global clinical studies evaluating the Paradise™ Ultrasound Renal Denervation (uRDN) system as a treatment for hypertension. Analysis demonstrated maintained blood pressure (BP) reduction following treatment with uRDN when compared to sham, with fewer antihypertensive treatments added in the treated group. The results were presented in a late-breaking session at Transcatheter Cardiovascular Therapeutics (“TCT”) — the annual scientific symposium of the Cardiovascular Research Foundation — by RADIANCE study co-principal investigator Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. The study results were simultaneously published in Circulation.

The RADIANCE Pooled Analysis includes data collected through six months follow-up from 506 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. Following the two-month primary endpoint for each study, if monthly home BP was uncontrolled from 2 to 5 months after randomization, medical antihypertensive treatments were sequentially added for both treated and sham groups to try to achieve a home BP reading of <135/85 mmHg, under continuous blinding. The combined analysis demonstrated fewer medications were added in the uRDN group at 6 months compared to sham. The difference in daytime ambulatory systolic blood pressure between groups after adjusting for the difference in medications was -3.0 mmHg (p=0.033) favoring uRDN. Similarly, office and home systolic blood pressure differences over 6 months were -5.4 mmHg (p<0.001) and -5.2 mmHg (p<0.001), respectively. Safety outcomes were few and did not differ between the groups.

“One of the key questions often asked about renal denervation is whether it is durable, especially in comparison to (or in combination with) antihypertensive medications. In this pooled analysis from the three sham-controlled clinical trials in the RADIANCE program, we observed a continued effect of uRDN at 6 months even with a backdrop of intensive monthly escalation of medications to try to achieve blood pressure control,” said Dr. Kirtane. “These data support the role of uRDN as a useful adjunct to established antihypertensive therapies.”

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