Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension

Atherosclerosis
Stephen WorthleyRoderic J Warren

Abstract

Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and performance of the second generation EnligHTN™ Renal Denervation System. This first-in-human, prospective, multi-center, non-randomized study included 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mmHg) with drug-resistant hypertension. The primary safety and performance objectives were to characterize, from baseline to 6 months post procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure. Renal artery denervation, using the second generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, 6, 12, 18 and 24 months by 19/7, 26/9, 25/7, 23/7, 25/8 and 27/9 mmHg, respectively (p ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or ...Continue Reading

Citations

Mar 8, 2018·American Journal of Physiology. Regulatory, Integrative and Comparative Physiology·Christopher T BanekJohn W Osborn
Nov 9, 2018·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Atsushi SakaokaKenichi Sakakura
Apr 15, 2020·Nature Reviews. Cardiology·Lucas LauderFelix Mahfoud
Sep 4, 2020·Current Hypertension Reports·Bo LiangNing Gu
Mar 19, 2019·Hypertension·Christopher T BanekJohn W Osborn
May 26, 2020·Current Problems in Cardiology·Oluwaseun A AkinseyeUzoma N Ibebuogu
Dec 31, 2019·Progress in Cardiovascular Diseases·Aashish GuptaJ Stephen Jenkins
Oct 29, 2020·Irish Journal of Medical Science·Sumeeyae HaribabuHaroon Zafar
May 1, 2021·Current Opinion in Cardiology·Tamunoinemi Bob-ManuelJose Tafur
Jul 23, 2019·Heart, Lung & Circulation·Sara I Al RaisiPramesh Kovoor

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