ReCor Medical today 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 Professor Thomas Zeller, MD and Dr. Elias Noory, MD.
"The initial procedures with the new Paradise System highlighted the new generator's ability to automatically customize energy delivery based on the patient's artery size while maintaining a consistent level of cooling protection," said Prof. Zeller and Dr. Noory. "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."
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.
"Last Friday's procedures using the new Radiance catheter with access via the radial artery marks a significant new approach to making the RDN procedure quicker, safer, and potentially more cost-effective for hospitals and patients," remarked Drs. Nicolas Van Mieghem and Joost Daemen from Erasmus Medical Center in Rotterdam, the Netherlands, who performed the first radial procedure. "This system's radial artery access and 10 second ablation time should allow us to treat a patient in a minimally invasive way within 30 minutes, and then let that patient go home the same day."
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.
"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," said ReCor Medical President & CEO, Andrew M. Weiss. "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."