Ovation 4A00120H01 Module

Original New I/O Module 4A00120H01

Description

The sample size of the study provided adequate statistical power for the evaluation of safety and effectiveness. The analysis included endpoints that were consistent with current literature on endovascular stent grafts. The primary safety hypothesis was tested by comparing the 30-day major adverse event (MAE) incidence in subjects treated with the Ovation device to a target performance goal of 21%1. The primary effectiveness hypothesis was tested by comparing the 12-month composite treatment success rate in subjects treated with the Ovation device to a target performance goal of 80%. For effectiveness endpoint evaluation, an independent core lab reviewed CT scans and abdominal x-rays to assess aneurysm changes, device position and integrity, and endoleaks.

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About us

High Five PLC Parts Limited is a professional engaged in the large-scale system (distributed control system, programmable controller, redundant fault-tolerant control systems, robot control system, large servo control system is the central feeding system plastic molding auxiliary equipment and automation of whole plant planning) imported automation system such as spare parts, modules, sales and system integration of high-tech enterprises. The company is equipped with professional technicians to provide customers with better service.