Overview of the 2023 FDA Circulatory System Devices Advisory Panel meeting on the Recor Paradise Ultrasound-Based Renal Denervation System. [Review] 

 -  2024 
<br/><br/>Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006 
<br/><br/> Hypertension continues to be a prominent, avoidable factor contributing to major vascular issues on a global scale. Even with lifestyle adjustments and more aggressive medical treatments, maintaining optimal blood pressure levels remains challenging. This challenge has driven the emergence of device-oriented approaches to address hypertension. To assess the safety and efficacy of the Recor Paradise Ultrasound Renal Denervation System, the Circulatory System Devices Panel was convened by the US Food and Drug Administration (FDA). This manuscript provides a condensed overview of the information put forth by the sponsor and the FDA, along with an account of the considerations and conversations that took place during the meeting. Copyright © 2024 Wiley Periodicals LLC. 
<br/><br/><br/>English 
<br/><br/><label>ISSN: </label>1522-1946 
<br/><br/><label>Subjects--Topical Terms: </label><br/>*Blood Pressure<br/>*Device Approval<br/>*Hypertension<br/>*Renal Artery<br/>*Sympathectomy<br/>*United States Food and Drug Administration<br/>Advisory Committees<br/>Equipment Design<br/>Humans<br/>Hypertension/pp [Physiopathology]<br/>Hypertension/su [Surgery]<br/>Kidney/bs [Blood Supply]<br/>Renal Artery/dg [Diagnostic Imaging]<br/>Renal Artery/ir [Innervation]<br/>Risk Factors<br/>Sympathectomy/ae [Adverse Effects]<br/>Sympathectomy/is [Instrumentation]<br/>Treatment Outcome<br/>United States--Automated
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Heart & Vascular Institute<br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Advanced Cardiac Catheterization Research Fellowship R<br/>Interventional Cardiology Fellowship
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article<br/>Review