ReCor Medical (Menlo Park, CA), makers of the only ultrasound based renal denervation system for control of hypertension, received clearance for its PARADISE Gen 2 device from European authorities. The original system was approved for sale a year ago and the new one improves it with an over-the-wire 6Fr device size and faster denervation.
All other known similar systems use low power radiofrequency waves to reduce sympathetic nervous system hyperactivity by denervating nerves in the renal artery walls. The system uses a balloon to position the transducer centrally in within the lumen to deliver consistent denervation and cooling evenly to the artery walls.
From the announcement:
“The benefit of ReCor’s ultrasound approach is three-fold,” explained Mano Iyer, CEO of ReCor Medical. “Firstly, PARADISE is designed to penetrate much deeper into the tissue, up to 8 millimeters; secondly, PARADISE delivers heat circumferentially, to target all of the renal nerves in one location; thirdly, PARADISE does this while simultaneously cooling the artery wall’s surface to protect the vessel.
“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,” said Iyer. “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.”
Product page: PARADISE (Percutaneous Renal Denervation System)…
(hat tip: MassDevice)