FDA Panel Votes in Favor of Renal Denervation Device for Hypertension
A U.S. Food and Drug Administration (FDA) advisory panel has voted in favor of the Paradise™ Ultrasound Renal Denervation (RDN) system, developed by Recor Medical, Inc. and its parent company Otsuka Medical Devices Co., Ltd. The device is indicated for the treatment of patients with hypertension, a condition characterized by high blood pressure. The panel’s overall vote suggests that there is sufficient data to support the use of the device in patients with uncontrolled hypertension.
During the meeting, the FDA’s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee discussed the pre-market approval application (PMA) for the Paradise system. The committee voted 12 to 0 in favor of the device’s safety and 8 to 3 in favor of its efficacy, with one abstention. Additionally, the committee voted 10 to 2 in favor of the benefits of the Paradise system outweighing the risks.
If the FDA approves the Paradise Ultrasound RDN system, it would become the first FDA-approved renal denervation device in the United States indicated for reducing blood pressure in patients with uncontrolled hypertension.
Hypertension is a leading cause of cardiovascular morbidity and mortality, and even with effective medications and lifestyle modifications, blood pressure control rates remain poor. Dr. Ajay Kirtane, a Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital and co-primary investigator in the RADIANCE Global Program studying the Paradise system, expressed his satisfaction with the committee’s recognition of the adjunctive benefits of the device in lowering blood pressure. Dr. Kirtane stated that the committee’s vote aligns with the high-level scientific evidence generated through the RADIANCE Global Program.
Lara Barghout, President and Chief Executive Officer of Recor Medical, expressed gratitude to the FDA and the advisory committee for their thorough review and discussion of the Paradise system for treating uncontrolled hypertension. Barghout highlighted the company’s continued collaboration with the FDA prior to the anticipated PMA approval and expressed confidence in the positive impact the Paradise Ultrasound RDN system could have in addressing the significant unmet need for effective hypertension treatment.
The PMA submission for the Paradise Ultrasound RDN system included data from three independent clinical trials conducted as part of Recor’s RADIANCE Global Program. These trials involved more than 500 patients with mild-to-moderate or resistant uncontrolled hypertension. The Paradise system already bears the CE mark for the treatment of hypertension and is currently under investigation in the United States and Japan.
Recor Medical, a subsidiary of Otsuka Medical Devices Co., Ltd., is dedicated to transforming the management of hypertension through medical technology. The positive outcomes reported in the clinical trials of the Paradise system contribute to its potential as an innovative solution for patients with hypertension. Otsuka Medical Devices Co., Ltd. focuses on developing and commercializing medical care products, including endovascular devices, to address areas where conventional treatment methods do not meet patient needs.
The FDA panel’s vote in favor of the Paradise Ultrasound RDN system brings hope for patients suffering from uncontrolled hypertension. The device’s approval would mark a significant milestone in the field of renal denervation and provide an alternative treatment option for individuals struggling to control their blood pressure. As the industry awaits the final decision from the FDA, the potential for the Paradise system to positively impact the lives of many remains strong.
