PALO ALTO, Calif. & FRANKFURT, Germany--(BUSINESS WIRE)--ReCor Medical, Inc. (“ReCor”), a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced today that the company’s Paradise™ Ultrasound Renal Denervation System (the “Paradise™ System”) is now available for the treatment of uncontrolled hypertension in Germany. The first hospitals performing the procedure commercially are Heart Center Leipzig and Saarland University Hospital, Homburg/Saar.
“Despite the availability of antihypertensive medications, many patients fail to control their hypertension, a dangerous condition that can lead to heart attack and death. Clinical data from the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO and TRIO trials show that ultrasound renal denervation with the Paradise System can lower blood pressure and is a new treatment option for physicians to help their selected patients,” said Prof. Felix Mahfoud of Saarland University Hospital and chairman of the Arterial Hypertension Working Group of the German Society of Cardiology (DGK), who served as study investigator for the RADIANCE-HTN SOLO and TRIO trials. “We are pleased to be one of the first hospitals in Europe to offer renal denervation with ultrasound.”
In Leipzig, the first procedure was successfully performed at the Heart Center Leipzig at the University Clinic for Cardiology. There, Prof. Dr. Philipp Lurz and PD Dr. Karl Fengler led the RADIOSOUND trial, and both have participated in the RADIANCE-HTN SOLO and TRIO studies in patients with uncontrolled hypertension.
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Paradise ultrasound renal denervation is a device-based, minimally invasive procedure for the treatment of high blood pressure. During the procedure, which usually takes less than an hour, the Paradise catheter is placed in the renal artery. Typically, three doses of ultrasound energy lasting a few seconds are applied to each of the main arteries leading to the kidneys. The ultrasound emissions denervate the renal nerves and cause a reduction in sympathetic nervous system activity, which can result in lower blood pressure.
In September 2021, the European Society of Hypertension published an updated position paper stating that renal denervation “is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity.” The society noted that five independent sham-controlled randomized clinical trials—including RADIANCE-HTN SOLO and TRIO—provide “conclusive evidence” that renal denervation can lower ambulatory and office blood pressure both in patients with and without concomitant antihypertensive medication.