Filing of Pre-Market Application Follows Successful Pivotal Trial of the Paradise uRDN System successful the Treatment of Uncontrolled Hypertension
PALO ALTO, Calif., November 30, 2022--(BUSINESS WIRE)--ReCor Medical, Inc. ("ReCor") and its genitor company, Otsuka Medical Devices Co., Ltd. ("Otsuka Medical Devices") contiguous announced the filing of the pre-market support (PMA) exertion to the U.S. Food and Drug Administration (FDA) for the Paradise™ uRDN System successful the attraction of uncontrolled hypertension.
The Paradise uRDN System is designed to trim sympathetic nervus enactment by denervating nerves which situation the renal arteries with the extremity of reducing humor pressure. Paradise uRDN uses a operation of ultrasound vigor to denervate the renal nerves and a water-filled balloon to support the renal artery. The Paradise uRDN System employs an interventional process successful which the Paradise catheter is placed successful each of the main renal arteries, pursuing which 2 to 3 seven-second ultrasound emissions are delivered to denervate the surrounding renal nerves, thereby reducing humor pressure.
Since 2009, ReCor has been focused connected processing and investigating the Paradise uRDN System to dainty hypertension safely and effectively. ReCor has 3 global, independently powered, sham-controlled randomized objective trials of the Paradise uRDN System successful much than 500 patients with uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II. Each RADIANCE proceedings met its prespecified superior efficacy endpoint of humor unit reduction, with affirmative safety.
RADIANCE II is the U.S. FDA IDE pivotal trial. In September of this year, ReCor and Otsuka Medical Devices announced that the proceedings successfully reached its superior efficacy endpoint. Results showed a simplification successful daytime systolic ambulatory humor unit of -7.9 mmHg successful those treated with uRDN and a quality betwixt uRDN and sham of -6.3 mmHg (p <0.0001). The results from the 3 RADIANCE objective trials person been included successful the submission for support to the U.S. FDA.
Hypertension is the starring contributor to illness load worldwide, resulting successful accrued cardiovascular morbidity and mortality, poorer prime of life, and higher costs to wellness systems. The Paradise uRDN System bears the CE people for the attraction of hypertension successful Europe and is an investigational instrumentality successful the United States and Japan.
About ReCor Medical, Inc.
ReCor Medical, headquartered successful Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is simply a aesculapian exertion institution focused connected transforming the absorption of hypertension. ReCor has pioneered the usage of the Paradise Ultrasound Renal Denervation (uRDN) System for the attraction of hypertension. The Paradise System is an investigational instrumentality successful the United States and Japan and bears the CE people successful the EU. ReCor has reported affirmative outcomes successful 3 independent, randomized, sham-controlled studies of the Paradise System successful patients with mild-to-moderate and resistant hypertension. In addition, ReCor has begun the Global Paradise System ("GPS") Registry successful the European Union, with plans to grow globally.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses connected the planetary improvement and commercialization of aesculapian attraction products including endovascular devices that supply caller therapeutic options successful areas wherever diligent needs cannot beryllium met done pharmaceutical oregon different accepted treatment. Otsuka Medical Devices Co., Ltd. is simply a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a planetary healthcare institution listed connected the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
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