CE Mark For Next Generation Ultrasound Renal Denervation System

In short

A year ago ReCor Medical’s first renal denervation offering joined the party. Now in another example of just how fast things are moving, the company has now received CE mark approval for its Generation 2(Gen2) device, an evolution of the original ultrasound-based Paradise™ system.

Background

ReCor Medical says its Paradise ultrasound catheter is designed with the aim to allow complete circumferential denervation more consistently and efficiently than the standard of care radiofrequency ablation catheter. The Paradise system is a minimally invasive 6Fr over-the-wire (OTW) ultrasound device for treating resistant high blood pressure using the, by now well-established, principles of renal denervation.

Compared with the original offering, the treatment parameters of Gen 2 have been further enhanced to reduce energy delivery to 30 seconds by maximising cooling of the endothelium and efficiently treating the nerves circumferentially. It has been reported that RF technologies generate unnecessary heating at the level of the arterial wall, which ReCor hopes plays into the hands of its ultrasound based technology. This is reinforced by data presented at TCT 2012, which concluded that renal nerves are actually much further at depth than previously thought, and run circumferentially around the renal arteries.

ReCor says its Gen 2 system considerably enhances efficiency while making the procedure easier and quicker.

It remains the only CE-marked system for renal denervation that is based on ultrasound, not radiofrequency (RF), energy.

Physician comments

“The Gen 2 O-T-W PARADISE system is designed to offer optimal non-invasive ultrasound therapy for resistant hypertension patients to reduce resistant high blood pressure,” said Professor 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”.

Company comments

“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.”

Regulatory status

Paradise is approved for sale in Europe; it is not approved for sale or investigational use in the United States.

Source: ReCor Medical, Inc., Business Wire