ReCor’s Paradise Ultrasound RDN System Evaluated in Pooled Data Analysis From RADIANCE SOLO and TRIO Studies

May 17, 2022—ReCor Medical, Inc. and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., announced the findings of a pooled data analysis from ReCor’s two randomized, sham-controlled trials evaluating the company’s Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension.

The company stated that the analysis demonstrated a statistically significant reduction in blood pressure (BP) across a broad range of hypertension severity as represented in the RADIANCE-HTN SOLO and TRIO studies. The RADIANCE-HTN studies were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory BP at 2 months. Both studies met their primary efficacy and safety endpoints.

Principal Investigator Ajay Kirtane, MD, presented the pooled data analysis in a late-breaking session titled “Hypertension management in 2022: control it, live longer” on World Hypertension Day at the EuroPCR 2022 conference held in May 17-22 in Paris, France.

According to Recor Medical, the pooled analysis combined data from 282 patients randomized in the two prospectively powered, sham-controlled studies that enrolled two disparate patient populations. TRIO was composed of patients with resistant hypertension and SOLO enrolled patients with mild-moderate hypertension.

The company reported consistent benefits in both BP reduction and medication burden across the pooled patient population compared to sham. The combined data set showed an overall between-group difference through 6 months favoring uRDN in daytime ambulatory systolic BP of -4.8 mm Hg (95% CI, -7.1 to -2.5; P < .001) and home systolic BP of -5.4 mm Hg (95% CI, -7.3 to -3.6; P < .001).

“The results of this pooled analysis make clear the consistent BP-lowering effect that uRDN can have across differing severities of hypertension, regardless of trial design and whether the enrolled patients are on or off antihypertensive medications,” commented Dr. Kirtane in the company’s press release. “Assuming continued safety of the procedure is demonstrated, uRDN is a promising treatment option complementary to lifestyle modification and medications for patients with uncontrolled hypertension.” Dr. Kirtane is Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital in New York, New York.

In the press release, the company advised that, in addition to RADIANCE-HTN SOLO and TRIO, the RADIANCE global program also includes the RADIANCE-II pivotal trial in the United States and Europe under an FDA investigational device exemption. RADIANCE-II will study the safety and effectiveness of the Paradise uRDN system to reduce BP in patients with hypertension, in the absence of antihypertensive medications. Those results will be presented to the scientific and medical communities later this year, stated the company.

Pending successful completion of RADIANCE-II, ReCor Medical will submit a premarket approval application to the FDA for market approval in the United States. On March 29, 2022, the company announced that enrollment was completed in RADIANCE-II.