1C31227G01 目前已获批准的Ovation腹部支架移植系统

描述

1C31227G01 目前已获批准的Ovation腹部支架移植系统

艾默生Emerson 1C31227G01 1C31227G01对目前已获批准的Ovation腹部支架移植系统进行了以下设计改进：1、目前批准的Ovation Prime主动脉体支架植入带完整导管鞘的改良主动脉体输送导管中，集成的交叉腔和更长的输送系统工作长度。2、目前批准的Ovation Prime和/或Ovation iX髂肢/髂骨延伸支架移植。

目前认可的CustomSeal套件通过稍微修改填充聚合物套件中的成分比例，缩短了填充聚合物固化时间(缩短了详细时间：14分钟vs.20分钟)。这些修改基于Ovation用户的反馈，并保持了艾默生Emerson 1C31227G01 OVATION西屋PLC模块平台的基本设计和技术特点。设计修改通过了试验验证。基于艾默生Emerson 1C31227G01 OVATION西屋PLC模块 iX腹部支架移植系统与艾默生Emerson 1C31227G01 OVATION西屋PLC模块腹部支架移植系统的相似性和非临床试验，从临床研究中获得的关于Ovation iX腹部支架移植系统的临床数据也适用于Ovation iX腹部支架移植系统。

1C31227G01 目前已获批准的Ovation腹部支架移植系统

Emerson 1C31227G01 1C31227G01 provides the following design improvements to the currently approved Ovation abdominal stent transplant system: 1. The currently approved Ovation Prime aortic body stent is implanted into an improved aortic body delivery catheter with a complete catheter sheath, integrated cross cavity and longer delivery system working length. 2. Currently approved Ovation Prime and/or Ovation iX iliac limb/iliac crest extension stent grafts.

The currently approved CustomSeal kit reduces the curing time of the filled polymer by slightly modifying the proportion of components in the filled polymer kit (reduced detail time: 14 minutes vs.20 minutes). These modifications are based on Ovation user feedback and maintain the basic design and technical features of the Emerson 1C31227G01 OVATION Westinghouse PLC module platform. The design modification has passed the test verification. Based on the similarities and non-clinical trials between the Emerson 1C31227G01 OVATION Westinghouse PLC Module iX abdominal Stent Transplant system and the Emerson 1C31227G01 OVATION Westinghouse PLC Module Abdominal Stent transplant system, The clinical data obtained from the clinical study on the Ovation iX abdominal stent transplant system are also applicable to the Ovation iX abdominal stent transplant system.