ReCor Medical has commenced a post-market Achieve study of its Gen-2 Paradise system, designed for use in patients with resistant high blood pressure.
Featuring an over-the-wire 6Fr device and faster procedures, the CE-marked minimally invasive ultrasound device optimizes nerve damage through a 30-second energy delivery and maximizes endothelial protection with its cooling mechanism.
The study 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 first patients in the study, enrolled at the Thoraxcenter 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 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 added.
"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."