ReCor Medical Begins ACHIEVE Postmarket Study of Paradise Renal Denervation System

February 14, 2013—ReCor Medical (Menlo Park, CA) announced that it has commenced the 50-patient, postmarket ACHIEVE study across multiple sites in Europe with its second-generation (Gen 2) Paradise system, a minimally invasive 6-F, over-the-wire (OTW) ultrasound device for treating resistant high blood pressure. The first two patients in the study were enrolled at the Thoraxcenter in Rotterdam, The Netherlands. Both patients were treated quickly with no device or procedural complications, reported the company.

ReCor Medical announced that it received CE Mark approval for the Paradise system on January 24. The device is approved for sale in Europe but it is not approved for sale or investigational use in the United States.

According to the company's announcement, the treatment parameters of the Gen 2 Paradise system have been enhanced to optimize nerve damage through a 30-second energy delivery while maximizing endothelial protection with its unique cooling mechanism. The company advised that the benefits of ReCor's Paradise ultrasound approach are that it penetrates deep into the tissue, where the majority of nerves are located; it delivers heat circumferentially, to target all of the renal nerves in one location; and it simultaneously cools the artery wall's surface to protect the vessel.