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The purpose of this study is to determine whether the AmnioFix Injectable human amniotic membrane is effective in the treatment of recalcitrant plantar fasciitis.
dehydrated human amniotic membrane processed through Surgical Biologic's proprietary Purion® process, which combines cleaning, dehydration and sterilization to produce a safe, technically sterilized tissue allowing for storage at room temperature.
AmnioFix® is processed from human tissue according to the American Association of Tissue Banks (AATB) standards, and is considered a tissue product under Section 361 of the Public Health Service Act. This means that AmnioFix® is regulated differently than the other two MiMedx platform technologies, CollaFix™ and HydroFix®, which are regulated as medical devices and therefore need FDA clearances prior to marketing in the United States. Since it is regulated as a tissue product, AmnioFix® does not need such clearance or approval in the United States.
Re: AmnioFix (amniotic membrance) injections for plantar fasciitis
Anyone else think this is ridiculous? Injecting a product made from human amniotic membrane for a condition that has a predominantly biomechanical cause?
Check out all the registered trademarks. Anyone else creeped out by the concept of research to assess the effectiveness of using human tissue to establish a market for the sale of this tissue? For bloody plantar fasciitis! I mean, corneal transplants and other organs, ok that makes sense. But amniotic membrane for heel pain? Crazy.
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Phil Marshman
Mackay, Queensland Australia
AmnioFix (amniotic membrance) injections for plantar fasciitis
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