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Here is another new paper about this. I’m kind of shocked at how much effort is put in to hiding the fact that this device is just a giant plug and patch. All of the words used to describe it seem meant to obfuscate and sensationalize. His latest paper seems to be claiming that the damaged tissue is completely recreated. The product is the ultimate hernia repair devices. It’s incredible. The selling is really accelerating for this one. Venture capital needs rapid returns.
One major flaw in the claims is that polypropylene fibers do not have good fatigue resistance. If what he claims is true, then the product will almost certainly fail from fiber fatigue and failure, from the constant motion that he describes. Lots of sharp pointy fiber ends in the defect. Polypropylene was probably chosen because it will slip through the 510(k) protocol for rapid market introduction. A good inventor would have researched the the fiber qualities needed for the product and went out and found the proper material. If the product does what he says it is almost guaranteed to fail. If it doesn’t, it’s just another plug.
https://www.mdpi.com/2079-4983/13/4/253
“Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin
by Giuseppe Amato 1,*,Giorgio Romano 1,Vito Rodolico 2ORCID,Roberto Puleio 3ORCID,Pietro Giorgio Calò 4ORCID,Giuseppe Di Buono 1,Luca Cicero 5,*,Giorgio Romano 6ORCID,Thorsten Oliver Goetze 7 andAntonino Agrusa 1”
“5. Conclusions
All of the above would appear to confirm that, unlike the ordinary 50-year-old treatment concept with conventional flat static meshes, the 3D dynamic responsive structure of the ProFlor device attracts tissue growth factors acting as a true regenerative scaffold. The updated physiological and pathogenetically coherent treatment concept embodied by ProFlor seems to represent a game changer in the intricate realm of inguinal hernia repair. Effectively, ProFlor probably embodies a new category of hernia devices presenting with completely new and updated concepts for the treatment of inguinal protrusions: fixation-free deployment, permanent defect obliteration, dynamic responsive behavior, and regenerative scaffold. These innovative concepts constitute a turning point for the cure of inguinal hernia and may represent the basis for the development of more advanced devices for the future therapy of this frequently occurring disease.”