ReCor Medical, a healthcare products manufacturer based in Menlo Park, California, announced that it had received CE Mark clearance from the European Union for its renal denervation system, dubbed Paradise.
Paradise is a minimally-invasive 6Fr wire-based ultrasound system for the treatment of drug-resistant hypertension. With the second-generation Paradise system, new treatment parameters reduce energy delivery times to 30 seconds through proprietary cooling techniques. This allows maximal cooling of a patient’s endothelium and enhances circumferential treatment of nerves.
According to a press release by the company, a live demonstration of the new system is planned for January 25th, 2013. The demonstration will take place at the Leipzig Interventional Course, held in Leipzig, Germany.
The first-generation Paradise system received CE Mark clearance in the E.U. in late 2011. The second-generation Paradise system includes several efficiency enhancements that make the procedure quicker and easier for both patients and doctors. As of now, the second-generation Paradise is the only CE Mark-approved device that uses ultrasound instead of radiofrequency energy for renal denervation.
Mano Lyer is the CEO of ReCor Medical. In prepared remarks, he said, "Our unique approach is in stark contrast to RF, which is limited in its depth of penetration to just a few millimeters, due to inconsistent arterial wall contact, as well as its inability to heat circumferentially in any given location.” He continued, "In addition, RF technologies generate unnecessary heating at the level of the arterial wall. 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 underscores the PARADISE ultrasound advantage."