ReCor Medical has announced major advances in its Paradise System for renal denervation (RDN), confirming its commitment to lead in the treatment of patients with resistant hypertension (HTN).
The company announced that it has received CE-mark for the latest generation of its ultrasound-based renal denervation system.
The first patients were treated with the new system in December, 2013 at the Universitats-Herzzentrum, Bad Krozingen, Germany, by Dr Thomas Zeller and Dr Elias Noory.
ReCor also announced the first use of its new catheter line, called Radiance, which is 5Fr and rapid-exchange compatible, and thus sized to be introduced via the radial artery – as opposed to the femoral artery.
The Paradise System is the only CE-Marked RDN system that uses radial ultrasound as its energy source – as opposed to radio frequency (RF) electrical energy – together with water-based convective cooling, allowing for the potential of faster procedures, more thorough renal denervation, and improved vessel safety.
ReCor Medical president and CEO Andrew Weiss noted following the recent publication of negative results from one of the RDN clinical trials, some competitors have announced that they are either delaying, reducing or abandoning efforts to commercialize their RF-based RDN products.
"Having reviewed our own clinical results and spoken to clinicians who have collectively treated hundreds of patients with resistant hypertension using different RDN systems, ReCor is convinced that our product is well-differentiated from these RF-based approaches.
"We remain convinced that RDN has the potential to become a key component of HTN therapy, and believe that our Paradise System provides the safe, reliable and complete denervation needed to become the category leader in this field," Weiss added.