ReCor Medical's Next-Generation Paradise Renal Denervation System Gains CE Mark

January 24, 2013—ReCor Medical (Menlo Park, CA) announced that it has received CE Mark approval for its second-generation (Gen 2) Paradise system, a minimally invasive, 6-F, over-the-wire (OTW) ultrasound device for renal denervation treatment of resistant high blood pressure. The treatment parameters of the Gen 2 Paradise device have been enhanced to reduce energy delivery to 30 seconds by maximizing cooling of the endothelium and efficiently treating the nerves circumferentially. The company noted that a live case featuring the device was conducted at the LINC 2013: Leipzig Interventional Course meeting in Leipzig, Germany.

CE Mark approval of the first-generation Paradise system was announced in February 2012. According to ReCor, the second-generation device considerably enhances efficiency while making the procedure easier and quicker. The company advised that the Paradise system is not approved for sale or investigational use in the United States.

“The Gen 2 OTW Paradise system is designed to offer optimal noninvasive ultrasound therapy for resistant hypertension patients to reduce resistant high blood pressure,” commented Professor Marc Sapoval, MD, in the ReCor press release. Prof. Sapoval is Chair of the Cardiovascular Radiology Department at Hôpital Européen Georges-Pompidou in Paris, France. “The new features of Gen 2, including an OTW 6-F device and a quicker procedure, offer patients a superior treatment option to reduce their blood pressure.”