ReCor Medical has received the CE mark for its next-generation Paradise system, a minimally invasive 6Fr over-the-wire (OTW) ultrasound device for treating resistant high bloodpressure. Additionally, the treatment parameters of this new device have been further enhanced to reduce energy delivery to 30 seconds by maximising cooling of the endothelium and efficiently treating the nerves circumferentially.
The Gen 1 Paradise system previously received CE mark just over one year ago. It is the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency (RF), energy.
“The Gen 2 over-the-wire Paradise system is designed to offer optimal non-invasive ultrasound therapy for resistant hypertension patients to reduce resistant high blood pressure,” said Marc Sapoval, chair of the Cardiovascular Radiology Department at Hôpital Européen Georges-Pompidou, Paris, France. “The new features of Gen 2, including an over-the-wire 6Fr device and a quicker procedure, offers patients a superior treatment option to reduce their blood pressure.”
“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 eight millimetres; 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 millimetres, 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.”
Paradise is not approved for sale or investigational use in the United States.