“The Paradise System has generated a significant body of clinical evidence in the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO studies—executed over a number of years in centers across the U.S. and Europe—showing a significant lowering of blood pressure in patients with uncontrolled hypertension,” said ReCor President and CEO Andrew M. Weiss. “The Paradise treatment offers patients and their caregivers a new option to treat their hypertension. We are pleased to make this new therapy available in Germany, and we look forward to introducing the Paradise System to more European countries soon.”

Hypertension is one of the leading contributors to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, impaired quality of life, and increased cost to health systems. Based on meta-analyses of randomized trials using pharmacological treatments, a decrease of 10 mmHg in office systolic blood pressure is estimated to lower the incidence of cardiovascular events by 20%. Despite the broad availability of antihypertensive medications, access to drugs and adherence remain challenging for patients and physicians.


The Paradise System is an investigational device in the United States. ReCor is currently conducting an FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension.


About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, Calif., is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. With its Paradise System ReCor has pioneered the minimally invasive use of ultrasound in renal denervation to treat patients with hypertension. The Paradise System is an investigational device in the United States. It is approved for sale in the EU and bears a CE mark. The company has completed two randomized, sham-controlled studies of the Paradise System in patients with both moderate hypertension and those resistant to standard medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion, will submit for PMA approval to market the therapy in the United States.

ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.


About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of 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 leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).

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