Spartan Medical Research Journal
Device and Patient-Related Complications of Renal Denervation for Uncontrolled Hypertension: A Post-Marketing Analysis of the FDA MAUDE Database
Introduction Renal denervation (RDN) has re-emerged as an adjunctive therapy for uncontrolled hypertension following recent U.S. Food and Drug Administration (FDA) approvals of ultrasound- and radiofrequency-based systems. Although randomized trials report a favorable safety profile, post-marketing data may reveal additional safety signals in real-world settings. Methods We performed a retrospective descriptive observational study of reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) databa …