ReCor Medical has announced that it has received CE-mark approval for the latest generation of its ultrasound-based renal denervation system (Paradise). It adds that the first patients were treated with the new system in December 2013 at the Universitäts–Herzzentrum, Bad Krozingen, Germany; the company also announced the first use of its new catheter line, called Radiance, which is 5 French and rapid-exchange compatible, and thus sized to be introduced via the radial artery (as opposed to the femoral artery).
“The initial procedures with the new Paradise System highlighted the new generator’s ability to automatically customise energy delivery based on the patient’s artery size while maintaining a consistent level of cooling protection,” said Thomas Zeller and Elias Noory (both at Universitäts–Herzzentrum, Bad Krozingen, Germany), who performed the first procedures. “Our first patient treated with the new Paradise System was a non-responder of two different radio frequency-based procedures. We are optimistic that the circumferential energy delivery of the Paradise ultrasound system will provide a more reliable treatment.”
A press release reports that the Paradise System is the only CE-marked renal denervation system that uses radial ultrasound as its energy source—as opposed to radio frequency electrical energy—together with water-based convective cooling, allowing for the potential of faster procedures, more thorough renal denervation, and improved vessel safety.