ReCor Medical announced today that it launched its Paradise ultrasound renal denervation system in Germany.
Palo Alto, California-based ReCor said in a news release that it made its Paradise system available for treating uncontrolled hypertension, with Heart Center Leipzig and Saarland University Hospital (Homburg/Saar).
The company designed its Paradise platform as a device-based, minimally invasive procedure for treating high blood pressure. The procedure usually takes less than an hour, with the Paradise catheter placed in the renal artery.
Usually, three doses of ultrasound energy lasting a few seconds are applied to each of the main arteries leading to the kidneys, with the ultrasound emissions denervating the renal nerves and causing a reduction in sympathetic nervous system activity, which can result in lower blood pressure.
The European Society of Hypertension last month 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 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,” ReCor president & CEO Andrew M. Weiss said in the release. “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.”
ReCor is currently conducting an FDA IDE pivotal study with the platform in patients with uncontrolled hypertension. Medtronic is touting upcoming results from its own renal denervation study as part of its efforts to build a billion-dollar business treating hypertension.