ReCor’s Paradise Ultrasound RDN System Shows BP-Lowering Effect at 24 Months in RADIANCE-HTN SOLO

November 4, 2021—Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., and its subsidiary ReCor Medical, Inc. announced the presentation of data from the RADIANCE-HTN SOLO trial demonstrating a durable blood pressure (BP)–lowering effect over 24 months for patients treated with Recor’s Paradise ultrasound renal denervation (RDN) system.

The data from the SOLO cohort of RADIANCE-HTN were presented in a poster session at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida.

According to the company, the SOLO study measured the BP-lowering effect of the Paradise system in patients with mild to moderate hypertension, taking no medications at study randomization. The study met its primary endpoint at 2 months when patients were off medications and showed a persistent BP-lowering effect at 6 and 12 months with fewer antihypertensive medications.

The results at 24 months in the SOLO trial confirm the persistence of a clinically relevant BP reduction in the patients treated with the Paradise system. The treated arm achieved a substantial 17.1 mm Hg mean reduction in office-measured systolic BP from baseline at 24 months, after introduction of an average of 1.2 oral antihypertensive medications. No adverse safety signals were observed, reported the company.

Coprincipal Investigator Professor Michel Azizi, MD, commented in the company’s press release, “Durability of the BP-lowering effect of RDN has been a focal point for many in the field of hypertension. The latest data from the RADIANCE-HTN SOLO trial show that the Paradise ultrasound RDN system’s treatment effect is still present at 24 months with no risk to patient safety, consistent with other long-term observational data.” Prof. Azizi is Professor of Medicine at Université de Paris and Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou in Paris, France.

As reported separately, findings from the RADIANCE-HTN TRIO cohort were presented in a late-breaking clinical trial session at TCT. The TRIO data showed that patients treated with the Paradise system maintained the device’s BP-lowering effect over 6 months.

Coprincipal Investigator Ajay J. Kirtane, MD, commented in the company’s press release, “The RADIANCE-HTN TRIO study demonstrates the efficacy and 6-month safety outcomes of the Paradise ultrasound RDN system in patients with resistant hypertension. After RDN, further reductions in BP were achieved with fewer added medications, particularly aldosterone antagonists. These data lend further support for the Paradise system as a potential treatment option for patients with resistant hypertension.” Dr. Kirtane is Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons in New York, New York.

Recor’s Paradise system has received European CE Mark approval. It is an investigational device in the United States. The Paradise system is currently under investigation in the United States and Europe in the ongoing FDA investigational device exemption pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated enrollment completion in 2022, advised the company.