Abstract:The scoring/cutting catheter is modified balloon catheter, which can be used in clinical practice as an adjunct to preparation
(pretreatment) or final treatment of choice. With the development and popularization of endovascular treatment for peripheral artery
diseases (PAD) in China, scoring/cutting catheter has become an important medical device in interventional therapy. This article
aims to summarize the working principle and mechanism of the scoring/cutting balloon, its technical characteristics and development
process, and the clinical application mentioned in the relevant expert consensus on PAD (mainly including lower extremity artery
stenosis, arteriovenous dialysis fistula stenosis, renal artery stenosis), so as to provide ideas for the validation, clinical evaluation and
technical review of such products.
王泽华,孟颖,盛恒松,王悦,刘英慧. 外周血管刻痕或切割球囊扩张导管的
临床应用及审评思考[J]. 中国医疗设备, 2023, 38(7): 159-163.
WANG Zehua, MENG Ying, SHENG Hengsong, WANG Yue, LIU Yinghui. Review of Clinical Application Studies on Peripheral Artery
Scoring/Cutting Balloon Dilation Catheters. China Medical Devices, 2023, 38(7): 159-163.