ReCor Medical and Otsuka Medical Devices Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (URDN) System to the US Food and Drug Administration

Filing of a Pre-Market Application Following Successful Pivotal Trial of the Paradise URDN System in the Treatment of Uncontrolled Hypertension

Palo Alto, California, November 30, 2022,business telegram)–ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the filing of a Pre-Market Approval (PMA) application with the US Food and Drug Administration (FDA) for the Paradise™ URDN System in the treatment of uncontrolled hypertension.

The Paradise URDN System is designed to reduce sympathetic nerve activity by spasming the nerves that innervate the renal arteries, with the goal of reducing blood pressure. The Paradise URDN uses a combination of ultrasound energy to deflate the kidney veins and a water-filled balloon to protect the kidney veins. The Paradise URDN System employs an interventional procedure in which Paradise catheters are placed into each of the main renal arteries, after which two to three seven-second ultrasound emissions are delivered to dislodge the surrounding renal veins, Due to which the blood pressure is reduced.

Since 2009, ReCor has focused on the development and testing of the Paradise uRDN ​​System to safely and effectively treat hypertension. ReCor has three global, independently powered, sham-controlled randomized clinical trials of the Paradise uRDN ​​System in more than 500 patients with uncontrolled hypertension: RADIANCE-HTN SOLO, RADIANCE-HTN TRIO and RADIANCE II. Each RADIANCE trial met its prespecified primary efficacy endpoint of reduction in blood pressure with positive safety.

Radiance II is the US FDA IDE conclusive test. In September of this year, ReCor and Otsuka Medical Devices announced that the trial successfully reached its primary efficacy endpoint. Results showed a decrease in daytime systolic ambulatory blood pressure of -7.9 mmHg in those treated with URDN and a difference between URDN and sham of -6.3 mmHg (p < 0.0001). Results from three RADIANCE clinical trials have been included in the submission to the US FDA for approval.

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Hypertension is a leading contributor to the burden of disease worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and high costs to health systems. The Paradise URDN System holds a CE mark for the treatment of hypertension in Europe and is an investigational device in the United States and Japan.

ReCor Medical, Inc. about

ReCor Medical, headquartered in Palo Alto, CA, Otsuka Medical Devices Co., Ltd. Ltd., a medical technology company focused on transforming the management of hypertension. ReCor pioneered the use of the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension. The Paradise System is a test tool in the United States and Japan and carries the CE mark in the European Union. ReCor has reported positive results in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild to moderate and resistant hypertension. In addition, ReCor has started the Global Paradise System (“GPS”) registry in the European Union, with plans to expand globally.

http://www.recormedical.com/

About Otsuka Medical Devices Co., Ltd.

Otsuka Medical Devices is focused 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 treatments. 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 (JP4578).

https://www.omd.otsuka.com/en/

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