PALO ALTO, Calif.–(Business WIRE)–ReCor Healthcare, Inc. (“ReCor”) and its mother or father corporation, Otsuka Health-related Units Co., Ltd. (“Otsuka Health-related Devices”) nowadays declared the submitting of the pre-industry approval (PMA) software to the U.S. Food stuff and Drug Administration (Food and drug administration) for the Paradise™ uRDN Process in the cure of uncontrolled hypertension.
The Paradise uRDN Technique is designed to cut down sympathetic nerve exercise by denervating nerves which encompass the renal arteries with the goal of reducing blood stress. Paradise uRDN works by using a combination of ultrasound energy to denervate the renal nerves and a drinking water-crammed balloon to protect the renal artery. The Paradise uRDN Technique employs an interventional technique in which the Paradise catheter is placed in each individual of the most important renal arteries, adhering to which two to three 7-second ultrasound emissions are shipped to denervate the bordering renal nerves, thus reducing blood pressure.
Because 2009, ReCor has been targeted on developing and tests the Paradise uRDN Procedure to handle hypertension securely and effectively. ReCor has three worldwide, independently run, sham-managed randomized medical trials of the Paradise uRDN Process in much more than 500 patients with uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II. Every single RADIANCE trial satisfied its prespecified key efficacy endpoint of blood strain reduction, with beneficial safety.
RADIANCE II is the U.S. Food and drug administration IDE pivotal demo. In September of this yr, ReCor and Otsuka Professional medical Gadgets announced that the demo correctly reached its key efficacy endpoint. Effects showed a reduction in daytime systolic ambulatory blood force of -7.9 mmHg in those people addressed with uRDN and a change in between uRDN and sham of -6.3 mmHg (p <0.0001). The results from the three RADIANCE clinical trials have been included in the submission for approval to the U.S. FDA.
Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poorer quality of life, and higher costs to health systems. The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.
About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is an investigational device in the United States and Japan and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension. In addition, ReCor has begun the Global Paradise System (“GPS”) Registry in the European Union, with plans to expand globally.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of medical care products including endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).