Treatment supported by evidence from multiple studies and Renal Denervation Position Paper from the European Society of Hypertension
Background
It’s been a long and rocky road for Renal Denervation as a treatment for resistant hypertension. Indeed it looked like it may have encountered an uncrossable chasm back in 2014 with the publication of data from the first major double blinded study that cast doubt on the therapy.
However 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.
Seven Years Later
Several of the major players pulled the plug on renal denervation projects years ago. Not so ReCor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. The company, with its Paradise™ ultrasound system, kept the faith and has now announced that it is now being made available for the treatment of uncontrolled hypertension in Germany. Find full release here.
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.
The first hospitals performing the procedure commercially are Heart Center Leipzig and Saarland University Hospital, Homburg/Saar.
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.
Clinician comments
“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.”
Company comments
“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.”
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.
Source: ReCor Medical, Inc.
