ReCor’s Paradise Renal Denervation System Studied in REQUIRE Trial in Japan and Korea

October 15, 2021—Otsuka Medical Devices Co., Ltd. (OMD), a subsidiary of Otsuka Holdings, Inc., and its subsidiary, ReCor Medical, Inc., announced results from the REQUIRE trial of ReCor’s Paradise ultrasound renal denervation system for the treatment of hypertension that was conducted in Japan and Korea. The trial was conducted by OMD and its affiliate.

“Catheter-Based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial” was presented at the 43rd annual scientific meeting of the Japanese Society of Hypertension held October 15-17, 2021, in Okinawa, Japan, and published simultaneously online by Principal Investigator Professor Kazuomi Kario, MD, et al in the journal Hypertension Research.

REQUIRE assessed the change in 24-hour ambulatory systolic blood pressure from baseline to 3 months in renal denervation and sham control groups.

According to OMD, the study did not show a significant difference in blood pressure reduction between the two groups, and therefore did not meet its primary efficacy endpoint. There were no significant differences in adverse events in the renal denervation and sham groups, demonstrating no difference in safety risk.

“The lack of difference in blood pressure reductions between the renal denervation and sham groups, and in particular the blood pressure reduction in the sham group, were not what we expected,” commented Prof. Kario, in OMD’s press release. “After in-depth analysis, we determined that the lack of effective medication stabilization and adherence control confounded the efficacy signal in both the treatment and sham groups. This, and other important insights from the REQUIRE study, are being taken into account as we design a future study of the Paradise system in Japan.”

Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine in New York, New York, stated in the announcement, “The REQUIRE results were not in line with the positive results we have observed in other trials with the Paradise system. As demonstrated in both RADIANCE-HTN SOLO and TRIO—two randomized, sham-controlled studies that met their blood pressure reduction primary endpoints—study design controls that reinforce medication adherence are necessary to reduce the variability of blood pressure results in both treatment and sham groups and are critical to assessing the true treatment effect in these trials. The REQUIRE study design did not standardize medications nor objectively measure adherence, which we believe thus caused the lack of a positive efficacy signal.”

Noriko Tojo, President of OMD, advised, “Otsuka Medical Devices, ReCor, and our scientific advisors are working to design a new randomized trial of the Paradise system in Japan. Based on the strong positive results from RADIANCE-HTN SOLO and TRIO, the root cause assessment of the REQUIRE efficacy signals, and the strong REQUIRE safety results, we are working with the Japanese regulatory authorities to plan a new randomized, controlled trial in uncontrolled, ‘on-med’ hypertension patients.”

The Paradise system has received CE Mark approval in Europe. In the United States, it is an investigational device. The company has completed two randomized, sham-controlled studies of the Paradise system in patients with both moderate hypertension and those resistant to standard medical therapies.

The Paradise system is under investigation in the United States and Europe in the on-going RADIANCE-II FDA investigational device exemption pivotal study in patients with uncontrolled hypertension. Enrollment completion expected in 2022. Pending successful completion of RADIANCE-II, Recor will submit an application for FDA premarket approval.