Brand New Original Module in stock EX06009

Description

The objective of the Ovation Abdominal Stent Graft System multicenter clinical study was to evaluate the safety and effectiveness of the Ovation Abdominal Stent Graft System in the treatment of subjects with AAA. The study was a prospective, consecutively enrolling, non-randomized multi-center clinical evaluation. A total of 161 subjects were enrolled in the pivotal study in the United States (111 subjects), Germany (30 subjects) and Chile (20 subjects). The sample size of the study was calculated based upon the primary safety evaluation. It was estimated that 150 subjects with evaluable data at 30 days would provide 96% statistical power to test the primary safety hypothesis (major adverse event [MAE] incidence of 11%) at the one-sided 0.05 level. A 15% attrition rate was anticipated through 12 months, which would yield approximately 128 subjects available to assess the primary effectiveness endpoint at 12 months. Should the rate for the primary effectiveness composite endpoint equal 88.2%, then 128 subjects would provide 80% power to test the primary effectiveness hypothesis at the onesided 0.05 alpha level.

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1.All the goods will be tested before shipment.
2.Packing in professional anti-static bag.
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