ReCor Medical's updated PARADISE (Percutaneous Renal Denervation) system has received CE Mark in Europe for treating resistant high blood pressure.
The 6 Fr over-the-wire ultrasound renal denervation device is designed to offer ultrasound therapy to reduce high blood pressure in treatment-resistant hypertension patients. The treatment parameters of Gen 2 have been enhanced to reduce energy delivery to 30 seconds by maximizing cooling of the endothelium and treating the nerves circumferentially.
The Gen 1 PARADISE system previously received CE Mark one year ago. It is the only CE-Marked system for renal denervation that is based on ultrasound, not radiofrequency energy, according to Menlo Park, Calif.-based ReCor, which developed the ultrasound system.
PARADISE is not currently available for clinical evaluation or sale in the U.S.