ReCor's Ultrasound-Based Paradise System Approved in Europe for Renal Denervation

January 28, 2014—ReCor Medical, Inc. (Palo Alto, CA) announced that it has received European CE Mark approval for the latest generation of its ultrasound-based Paradise renal denervation system for the treatment of patients with resistant hypertension. ReCor also announced the first use of Radiance, a 5-F catheter line that is rapid-exchange compatible and sized to be introduced via the radial artery.

The company noted that the Paradise system uses radial ultrasound as its energy source—rather than radiofrequency electrical energy—with water-based convective cooling, allowing for the potential of faster procedures, more thorough renal denervation, and improved vessel safety. The Paradise system is not approved for sale or investigational use in the United States, advised ReCor Medical.

Professor Thomas Zeller, MD, and Elias Noory, MD, treated the first patients with the new Paradise system in December 2013 at the Universitats–Herzzentrum in Bad Krozingen, Germany.

In the company’s press release, Prof. Zeller and Dr. Noory commented, “The initial procedures with the 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. Our first patient treated with the new Paradise system was a nonresponder of two different radiofrequency-based procedures. We are optimistic that the circumferential energy delivery of the Paradise ultrasound system will provide a more reliable treatment.”

Drs. Nicolas Van Mieghem and Joost Daemen from Erasmus Medical Center in Rotterdam, the Netherlands, performed the first radial procedure using the Radiance catheter. 

In the company’s announcement, Drs. Van Mieghem and Daemen commented, “Last Friday’s procedures using the new Radiance catheter with access via the radial artery marks a significant new approach to making the renal denervation procedure quicker, safer, and potentially more cost effective for hospitals and patients. 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.”