ReCor Medical has begun a post-market study of its new minimally invasive ultrasound device used to treat patients with resistant high blood pressure.
The CE-marked Gen-2 Paradise system, which performs procedures faster and more effectively than radiofrequency, features an over-the-wire 6Fr device and provides patients with a noninvasive treatment option to reduce blood pressure.
In addition, the system optimises nerve damage through a 30-second energy delivery, and maximises endothelial protection with its cooling mechanism, according to the company.
The study, Achieve, has enrolled 50 patients across multiple sites in Europe to assess the potential of the new system in treating resistant high blood pressure.
The company said that the first patients in the study, enrolled at the Thoraxcentre in Rotterdam, Netherlands, were treated with no device or procedural complications.
ReCor Medical CEO Mano Iyer said the new ultrasound device is considered to be more effective than a radiofrequency (RF) system, as it penetrates the energy deep into the tissue where the majority of nerves are located and delivers heat circumferentially.
"Equally important, RF technologies generate unnecessary heating at the level of the arterial wall," Iyer said.
"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."