Ovation EX06098 Module

Brand New Original Module in stock EX06098

Description

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

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Packaging & Shipping

1.All the goods will be tested before shipment.
2. Packing in professional anti-static bag.
3. We can ship to you by DHL/TNT/UPS/Fedex... Pls contact us directly.

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