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The study follows a dedicated flow visualization test plan aligned with ISO 5840-3 Annex N.4.3.5,6 pulsatile-flow visualization requirements and is optimized with best practices from the 2011 FDA PIV benchmark publication. Findings report acceptable aortic flow patterns over the full cardiac cycle, with broad central systolic jets and no retrograde diastolic jet-like flow.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/valvex-heart-valves-piv-test-report-scope-and-results/253254/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/valvex-heart-valves-piv-test-report-scope-and-results/253254.png","ImageObject",442,249,{"name":88,"@type":89},"Rizky","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-30","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",8,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the scope of the ValveX PIV test report?","Question",{"text":109,"@type":110},"The scope includes qualitative assessment of fluid motion via high speed video recording and quantitative assessment of velocity fields and both viscous and Reynolds shear stresses induced by flow through ValveX heart valves.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"Which standards and publications guide the testing procedures?",{"text":114,"@type":110},"The study is conducted in accordance with the referenced test plan and aligned with ISO 5840-3 Annex N.4.3.5,6 for pulsatile-flow testing, while procedures are optimized using best practices from the 2011 FDA PIV publication.",{"name":116,"@type":107,"acceptedAnswer":117},"What flow behaviors were observed during systole and diastole?",{"text":118,"@type":110},"During systole, a broad central jet-like flow was observed without flow stasis regions, and the valves opened efficiently and symmetrically. During diastole, no retrograde jet-like flow was observed.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},253254,1791418127,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":141,"read_time":142},962085564807,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","| Report \\#: | TR-\\#\\#-\\#\\# |  |\n| --- | --- | --- |\n| Date of Issue: mm/dd/yyyy | 09/15/2014 |  |\n| Testing Laboratory | ViVitro Labs\u003Cbr>455 Boleskine\u003Cbr>Victoria, BC\u003Cbr>Canada V8Z 1E7 |  |\n| Client | ValveX |  |\n| Test Methods | QV-504 Flow Visualization Test Method |  |\n| Items Tested | Manufacturer:\u003Cbr>Device Name: Model\\#:\u003Cbr>Size: | ValveX\u003Cbr>ValveXX\u003Cbr>X |\n| Study Director Mechanical Engineer Quality Assurance | Name: Devesh Amatya, PhD Signature:   Date:  Name: Oleksandr Barannyk, PhD Signature:   Date: \u003Cbr>Name: Vesna Janic Signature:   Date:  |  |\n\nTable Of Contents  \n1. Scope .................................................................................................................................................. 2  \n2. Executive Summary ............................................................................................................................ 2  \n3. Reference Documents ........................................................................................................................ 3  \n4. Samples .............................................................................................................................................. 4  \n5. Equipment and Materials .................................................................................................................... 4  \n6. Test Method ........................................................................................................................................ 4  \n7. Results .............................................................................................................................................. 11  \n8. Limitations of the current study......................................................................................................... 13  \n9. Conclusions ...................................................................................................................................... 13  \n10. Appendix A. Quantitative Flow Visualization ................................................................................... 14  \n11. Appendix B. Qaulitative Flow Visualization ..................................................................................... 17  \n12. Appendix C. PIV Test Conditions .................................................................................................... 19  \n1. Scope  \nThe scope of this test report includes a qualitative assessment of fluid motion by means of high speed video recording of the flow in the immediate vicinity of the device , and a quantitative assessment of the velocity fields and both viscous and Reynolds shear stresses induced by the flow through ValveX heart valves.  \nThis study was conducted in accordance with Test Plan \\#\\#-\\#\\# (Reference Document 3 .4) .  \nThe scope of this test plan is intended to meet the requirements of: ISO 5840-3 Annex N.4.3.5,6 Pulsatile-Flow Testing – Flow Visualization Testing.  \nTesting procedures were optimized to follow the best practices for PIV measurements found in the 2011 FDA publication (Reference Document 3.7) .  \n2. Executive Summary  \nValveX offers acceptable aortic flow patterns throughout the entire cardiac cycle. During systole a broad central jet-like flow without regions of flow stasis were observed in all ValveX valves. The valves open efficiently and symmetrically. During diastole no retrograde jet-like flow was observed. Both viscous shear and Reynolds stresses are comparable to similar devices in the market.  \n3. Reference Documents  \n3.1. QV-405 Laboratory Valve Handling, Sanitization and Security  \n3.2. QV-407 Blood Analog Solution Preparation  \n3.3. QV-503 Test Method for Flow Field Visualization  \n3.4. TP-\\#\\#-\\#\\# Test plan for flow visualization of ValveX aortic valves  \n3.5. ISO 5840 – 3 “Cardiovascular implants—Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques”  \n3.6. Draft Guidance for Industry and FDA Staff: Heart Valves - In","cbCaifZQQvAgP4AT","https://ap.wps.com/l/cbCaifZQQvAgP4AT","pdf",2334248,19,"English","# 1. Scope\n# 2. Executive Summary\n# 3. Reference Documents\n# 4. Samples\n## 1. Test Sample\n## 2. Reference Sample","[{\"question\":\"What is the scope of the ValveX PIV test report?\",\"answer\":\"The scope includes qualitative assessment of fluid motion via high speed video recording and quantitative assessment of velocity fields and both viscous and Reynolds shear stresses induced by flow through ValveX heart valves.\"},{\"question\":\"Which standards and publications guide the testing procedures?\",\"answer\":\"The study is conducted in accordance with the referenced test plan and aligned with ISO 5840-3 Annex N.4.3.5,6 for pulsatile-flow testing, while procedures are optimized using best practices from the 2011 FDA PIV publication.\"},{\"question\":\"What flow behaviors were observed during systole and diastole?\",\"answer\":\"During systole, a broad central jet-like flow was observed without flow stasis regions, and the valves opened efficiently and symmetrically. During diastole, no retrograde jet-like flow was observed.\"}]","ValveX Heart Valves PIV Test Report - Scope and Results | PDF",1789264914,7]