ReCor Medical has announced that its Paradise percutaneous renal denervation system ultrasound platform for achieving renal denervation has received CE mark. Paradise is designed to treat patients with ‘resistant’ hypertension.
Paradise includes a 6 French-compatible catheter with a cylindrical transducer that emits ultrasound energy circumferentially, allowing for a rapid and highly efficient renal denervation procedure. The advantage of Paradise is its ability to uniformly denervate all the way around the arterial wall while simultaneously cooling the endothelium, to help enable a safe, consistent, and fast renal denervation procedure.
The first-in-man clinical data for Paradise were reported at the “TRenD 2012” transcatheter renal denervation scientific meeting in Frankfurt, Germany, by Thomas A Mabin, Vergelegen Medi-Clinic, South Africa. The Paradise data showed that systolic blood pressure was reduced by an average of 31 mm Hg in 7 patients at 60-day follow-up.
“PARADISE is designed to offer a minimally invasive ultrasound therapy to resistant hypertension patients to help reduce their blood pressure,” said Mano Iyer, CEO, ReCor Medical. “We are extremely pleased with our first-in-man clinical results as we prepare to launch Paradise in Europe.”
“The initial results with Paradise are impressive,” said Marc Sapoval, Hôpital Européen Georges-Pompidou, Paris,France, who is a member of ReCor Medical’s Medical Advisory Board. “This degree of blood pressure reduction has significant health benefits for patients.”
Paradise is not yet approved for sale or investigational use in the United States.