ReCor Medical announced today that it has commenced a 50-patient, post-market study across multiple sites in Europe with its CE-marked next-generation PARADISE system, a minimally invasive 6Fr Over-The-Wire (OTW) ultrasound device for treating resistant high blood pressure. The first patients in the study have been enrolled at the Thoraxcenter, Rotterdam, the Netherlands. Both patients were treated quickly with no device or procedural complications.
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. PARADISE is the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency (RF), energy.
"The enhanced features of our Gen-2 PARADISE System, including an over-the-wire 6Fr device and a faster procedure, are designed to offer patients a superior, noninvasive treatment option to reduce their blood pressure," said Mano Iyer, CEO of ReCor Medical.
The benefit of ReCor's PARADISE ultrasound approach is three-fold: (1) to penetrate deep into the tissue where the majority of nerves are located; (2) to deliver heat circumferentially, to target all of the renal nerves in one location; (3) to simultaneously cool the artery wall's surface to protect the vessel.
"Our novel ultrasound approach is designed to be more effective than radiofrequency (RF), which is restricted in its depth of penetration to just a few millimeters because of inconsistent arterial wall contact, in addition to RF's inability to heat circumferentially in any given location," added Iyer. "Equally important, RF technologies generate unnecessary heating at the level of the arterial wall. Indeed, data presented at TCT 2012 concluded that renal nerves are actually much further at depth than previously thought, and run circumferentially around the renal arteries, which dramatizes the PARADISE ultrasound clinical advantage."