Abstract：
Hypertension remains a leading preventable cause of myocardial infarction, stroke, kidney disease, and cardiovascular death worldwide. Despite lifestyle modifications and intensification of medical therapy, suboptimal blood pressure control is common, spurring the development of device-based therapies for hypertension. The US Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel on August 22-23, 2023, to discuss the safety and effectiveness of renal denervation devices manufactured by Recor Medical and Medtronic. After reviewing the ultrasound-based Recor Paradise renal denervation system the day prior, the panel reconvened to discuss the radiofrequency-based Medtronic Symplicity Spyral Renal Denervation System. In this manuscript, we summarize the data presented by the sponsor and FDA and detail the deliberation and discussion during the meeting.
摘要：
高血压仍然是心肌梗死的主要可预防原因，中风,肾病,和全世界的心血管死亡。尽管生活方式的改变和药物治疗的强化，血压控制欠佳是常见的，促进基于设备的高血压疗法的发展。美国食品和药物管理局（FDA）于2023年8月22日至23日组装了循环系统设备小组，以讨论由RecorMedical和Medtronic制造的肾脏去神经支配设备的安全性和有效性。在前一天检查了基于超声的RecorParadise肾脏去神经系统后，小组讨论基于射频的MedtronicSymplicitySpyral肾脏去神经系统。在这份手稿中,我们总结了申办方和FDA提交的数据,并详细说明了会议期间的审议和讨论.
