Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension.
Yu SatoRika KawakamiAtsushi SakamotoAnne CornelissenMasayuki MoriKenji KawaiLiang GuoMaria E RomeroFrank D KolodgieRenu VirmaniAloke V FinnPublished in: Future cardiology (2021)
Catheter-based renal denervation is a novel treatment approach for patients with hypertension and initial unblinded trials have shown promising results. The Paradise™ Ultrasound Renal Denervation System (ReCor Medical, CA, USA) is an ultrasound-based catheter with a distal balloon that acts as a coolant to protect the renal arterial wall. This device received CE-mark in 2012. Randomized, sham-controlled trials and postmarket studies have shown promising efficacy and safety results. Currently, three additional ongoing randomized, sham-controlled trials are underway in the USA, Europe, Japan and Korea, and the results will be pivotal in device approval in some of these countries. These studies with larger numbers of patients and longer duration of follow-up are needed to further confirm the safety and efficacy of this device.
Keyphrases
- double blind
- blood pressure
- magnetic resonance imaging
- ultrasound guided
- end stage renal disease
- open label
- placebo controlled
- clinical trial
- healthcare
- phase iii
- chronic kidney disease
- ejection fraction
- prognostic factors
- computed tomography
- phase ii
- peritoneal dialysis
- minimally invasive
- contrast enhanced ultrasound
- replacement therapy
- protein kinase
- drug administration