超声软组织手术设备用于闭合7mm以内血管的临床评价思路

Clinical Evaluation Thoughts on Ultrasonic Surgical Devices for Sealing Vessels Up to 7mm in Diameter

超声软组织手术设备是一种兼有切割和止血功能的有源手术器械,具有效率高、出血少、创伤小等优势,目前已广泛应用于临床。文章梳理了中美两国的超声软组织手术设备上市前监管情况,以及超声软组织手术设备用于闭合7mm以内血管的临床评价思路,以期为该类产品的临床评价和技术审评提供借鉴。

Ultrasonic surgical devices are used for coagulation and cutting soft tissue,with advantages like high efficiency,bleeding control,and minimal thermal injury.Ultrasonic surgical devices have been widely used in clinical practice.This article reviews the pre-market regulatory requirements of ultrasonic surgical devices in China and the US,as well as the clinical evaluation approach of ultrasonic surgical devices for sealing vessels up to 7mm in diameter,so as to provide ideas for the clinical evaluation and technical review of such products.