ReCor Medical has received CE mark for its PARADISE (Percutaneous Renal Denervation System) ultrasound platform for renal denervation. The PARADISE is designed to treat patients with resistant hypertension. It does this by reducing sympathetic nervous system hyperactivity by denervating sympathetic nerves in the renal artery walls, which may be the primary mechanism by which the kidneys contribute to systemic 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.
If this all sounds familiar to you, that might be because the system is based on the same principles as the Medtronic Symplicity system which we have reported on multiple times in the recent past. Although both systems provide catheter-based denervation, the main differences are that the PARADISE uses ultrasound waves, while the Symplicity uses low-power radiofrequency waves. The PARADISE also uses a low-pressure balloon which allows for self-centering of the transducer for possibly more uniform, circumferential denervation and for cooling of the artery wall minimizing damage to non-targeted tissues.
A first trial in humans showed similarly impressive results as those achieved with the Symplicity system: reductions in systolic blood pressure of about 30 mmHg in patients with resistant hypertension (unresponsive to at least three antihypertensives).
Press release: ReCor Medical Announces CE Mark Approval for Its Novel PARADISE Ultrasound Transcatheter Renal Denervation System…
Product page: ReCor PARADISE…
