ReCor’s Paradise Ultrasound Renal Denervation System Launched in Europe

October 6, 2021—ReCor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., announced the commencement of the launch of the company’s Paradise ultrasound renal denervation system in Europe. 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 in Leipzig, Germany, and Saarland University Hospital in Homburg/Saar, Germany.

Professor Felix Mahfoud, MD, with Saarland University Hospital, served as study investigator for the RADIANCE-HTN SOLO and TRIO trials of the Paradise system. He is also chairman of the Arterial Hypertension Working Group of the German Society of Cardiology.

Prof. Mahfoud commented in the company’s press release, “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. We are pleased to be one of the first hospitals in Europe to offer renal denervation with ultrasound.”

The company noted that the Paradise ultrasound renal denervation procedure usually takes less than 1 hour. The Paradise catheter is placed in the renal artery, and 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.

ReCor Medical further advised that 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 paper noted that five independent sham-controlled randomized clinical trials, including ReCor’s RADIANCE-HTN SOLO and TRIO studies, provide “conclusive evidence” that renal denervation can lower ambulatory and office blood pressure in patients with and without concomitant antihypertensive medication.

In the United States, the Paradise system is an investigational device that is currently being evaluated in the company’s RADIANCE-II pivotal study of patients with uncontrolled hypertension. ReCor is conducting the study under an FDA investigational device exemption.