FDA approves Recor Medical’s Paradise Ultrasound RDN System for hypertension treatment

The U.S. Food and Drug Administration (FDA) has granted approval to Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd., for the Paradise Ultrasound Renal Denervation (RDN) system. This groundbreaking technology presents a new adjunctive option for the treatment of patients whose hypertension is not adequately controlled by traditional means.

A New Adjunctive Hypertension Treatment Emerges

The Paradise Ultrasound RDN system, now FDA-approved, is positioned as an additional treatment for hypertension alongside lifestyle modifications and medication. It leverages ultrasound-based RDN technology to target and calm overactive sympathetic nerves around the renal arteries, contributing to elevated blood pressure. This system, which includes the unique HydroCooling feature, ensures safety during the procedure while efficiently delivering ultrasound energy.

Clinical Studies Back FDA Approval

Recor’s innovation comes after a favorable FDA Advisory Committee Panel review in August 2023 and positive results from the RADIANCE II Randomized Clinical Trial published in the Journal of the American Medical Association (JAMA). With no major adverse events reported, the Paradise system achieved primary safety and effectiveness endpoints. “We look forward to making this technology available to physicians and their patients nationwide,” said Recor’s CEO Lara Barghout, reflecting on the rigorous journey towards FDA approval.

A Decade of Development Yields Results

Since 2009, Recor has dedicated efforts to perfecting the Paradise Ultrasound RDN system for hypertension. Their global RADIANCE program, which encompasses over 500 patients across three clinical trials, has consistently met safety and efficacy goals. This technology stands out for its efficacy in diverse patient groups, from those with mild to moderate hypertension to those with resistant hypertension, as noted by Naomi Fisher, MD, from Harvard Medical School.

Anticipating Global Impact on Hypertension Management

With the approval of the Paradise Ultrasound RDN system, Otsuka Medical Devices anticipates a significant advancement in treatment options for managing hypertension. “We are excited for patients and their healthcare professionals to have access to this technology,” stated Noriko Tojo, President of Otsuka Medical Devices. Hypertension, a leading cause of global disease burden, now faces a new formidable opponent in the Paradise Ultrasound RDN system, already making strides in Europe and under investigation in Japan.