Ovation 5X00457G04 Module New In Box

Brand New Ovation 5X00457G04 Module One year warranty

Description

The objective of the Ovation Abdominal Stent Graft System multicenter clinical study was to evaluate the safetyand effectiveness of the Ovation Abdominal Stent Graft System in the treatment of subjects with AAA. Thestudy was a prospective, consecutively enrolling, non-randomized multi-center clinical evaluation. A total of 161subjects were enrolled in the pivotal study in the United States (111 subjects), Germany (30 subjects) andChile (20 subjects).The sample size of the study was calculated based upon the primary safety evaluation. It was estimated that150 subjects with evaluable data at 30 days would provide 96% statistical power to test the primary safetyhypothesis (major adverse event [MAE] incidence of 11%) at the one-sided 0.05 level. A 15% attrition rate wasanticipated through 12 months, which would yield approximately 128 subjects available to assess the primaryeffectiveness endpoint at 12 months. Should the rate for the primary effectiveness composite endpoint equal88.2%, then 128 subjects would provide 80% power to test the primary effectiveness hypothesis at the onesided 0.05 alpha level.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. Theprimary safety hypothesis was tested by comparing the 30-day major adverse event (MAE) incidence insubjects treated with the Ovation device to a target performance goal of 21%1. The primary effectivenesshypothesis was tested by comparing the 12-month composite treatment success rate in subjects treated withthe Ovation device to a target performance goal of 80%. For effectiveness endpoint evaluation, an independentcore lab reviewed CT scans and abdominal x-rays to assess aneurysm changes, device position and integrity,and endoleaks

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FAQ:

1.Is the part new? 
   Yes, 100% Original brand new
2.How is the package?
   Original factory seal packed
3.What is the lead time?
   In stock: 1-3 working days
4.What is the MOQ: 
   1pcs
5.What is the payment term:
   TT and Western Union, other negotiable
6.Where the item ship from?
   Dammam
7.What is the warranty time?
   One year

8. How to delivery the PLC Parts?
   Kindly tell us your address,we check best cost for you
   Or you can use your own courier account or agent, DHL, FEDEX, UPS etc are available.

About Us

Jak PLC for many years, is a professional engaged in 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.

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