ReCor Medical has announced the start of ACHIEVE, a 50-patient post-market study of the company’s CE marked next-generation, ultrasound-based renal denervation system (Paradise) that will be conducted across multiple sites in Europe.
According to a company press release, the Paradise system is a minimally invasive 6Fr over-the-wire ultrasound device for treating resistant hypertension. The first two 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 press released reported that the treatment parameters of the next-generation Paradise system have been enhanced to optimise nerve damage through a 30-second energy delivery while maximising endothelial protection with its unique cooling mechanism. It is the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency 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, non-invasive treatment option to reduce their blood pressure,” said Mano Iyer, chief executive officer of ReCor Medical.
“Our novel ultrasound approach is designed to be more effective than radiofrequency, which is restricted in its depth of penetration to just a few millimetres because of inconsistent arterial wall contact, in addition to radiofrequency’s inability to heat circumferentially in any given location,” added Iyer. “Equally important, radiofrequency 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 dramatises the Paradise ultrasound clinical advantage.” He said.