ReCor Medical and Otsuka Medical Devices Announce Submission of Application for Pre-Market Approval of the Paradise™ Ultrasound Renal Denervation (uRDN) System to the U.S. Food and Drug Administration
Filing of Pre-Market Application Follows
Successful Pivotal Trial of the Paradise uRDN System in the
Treatment of Uncontrolled Hypertension
ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka
Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today
announced the filing of the pre-market approval (PMA) application
to the U.S. 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 denervating nerves which surround the renal arteries
with the goal of reducing blood pressure. Paradise uRDN uses a
combination of ultrasound energy to denervate the renal nerves and
a water-filled balloon to protect the renal artery. The Paradise
uRDN System employs an interventional procedure in which the
Paradise catheter is placed in each of the main renal arteries,
following which two to three seven-second ultrasound emissions are
delivered to denervate the surrounding renal nerves, thereby
reducing blood pressure.
Since 2009, ReCor has been focused on developing and testing the
Paradise uRDN System to treat hypertension safely and effectively.
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 blood pressure reduction,
with positive safety.
RADIANCE II is the U.S. FDA IDE pivotal trial. In September of
this year, ReCor and Otsuka Medical Devices announced that the
trial successfully reached its primary efficacy endpoint. Results
showed a reduction 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). 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).
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