ReCor Medical Moves Forward with Renal Denervation System

ReCor Medical claims it has made gains with its Paradise System for renal denervation. The company seems to be confirming its commitment to a technology used to treat patients with drug-resistant hypertension (high blood pressure) that has come under some scrutiny recently.

The company 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 at the Universitats–Herzzentrum, Bad Krozingen, Germany, by Thomas Zeller, M.D., and Elias Noory, M.D.

“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 Zeller and Noory said in a prepared statement.  “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 5 Fr 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,” according to Nicolas Van Mieghem, M.D., and Joost Daemen, M.D., 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 renal denervation system that uses radial ultrasound as its energy source instead of  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 (renal denervation0 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 and 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.”