Enhanced angiogenesis in the 3D dynamic responsive implant for inguinal hernia repair ProFlor

Amato, Giuseppe; Rodolico, Vito; Agrusa, Antonino; Calò, Pietro Giorgio; Buono, Giuseppe Di; Goetze, Thorsten Oliver

doi:10.1111/aor.13926

Cited by 8 publications

(11 citation statements)

References 56 publications

(133 reference statements)

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“…It must also be stated that more than 90% of hernia defects overall encountered in our clinical practice are less than 35 mm. For future cases of defects greater than 37 mm the planned solution involves delivering two 3D hernia devices connected together as previously documented in open ProFlor technique through a 12 mm channel 24 . Lastly, we are well aware that to be fully validated these results should be compared with those obtained with other laparoscopic techniques for inguinal hernia repair.…”

Section: Discussionmentioning

confidence: 99%

“…These adverse phenomena do not occur in ProFlor that, positioned fixation free to permanently obliterate the defect, moves in tune with the inguinal backwall. Lastly, ProFlor does not shrink because its intrinsic dynamic responsivity induces a unique biologic response with development of newly formed vessels, nerves and muscle fibers characterizing this 3D device as a regenerative scaffold [20][21][22][23][24] . These proprietary features of ProFlor embody a substantial difference to patch and plug technique.…”

Section: Discussionmentioning

confidence: 99%

“…This 3D hernia device is made of polypropylene material like conventional hernia prosthetics but owns inherent springiness, is positioned fixation free and, moving together with the groin, induces a probiotic biologic response. Modulated by specific growth factors, the development of newly formed connective tissue, vessels, nerves and muscles within the 3D scaffold has been documented in a series of scientific studies [19][20][21][22][23][24] . These proprietary regenerative effects, likely result of its intrinsic dynamic responsivity, allow the categorization of this new inguinal hernia device not as a conventional implant but rather a regenerative scaffold.…”

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confidence: 99%

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Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor

Amato

Agrusa

Calò

et al. 2022

Sci Rep

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Laparoscopic TAPP/TEP approaches are well-established options for the cure of inguinal hernias. As in the open approach, mesh fixation and poor-quality biologic response represent controversial questions and are a source of concerns. Furthermore, hernia defect patency represents another problem which seems not well acknowledged among surgeons. These problems are considered the cause of frequent intra and postoperative complications. To overcome these concerns, recently a different concept of cure has emerged. Based on a newly developed dynamic responsive 3D scaffold named ProFlor, a permanent hernia defect obliteration has been finalized. Following its inherent centrifugal expansion due to its dynamic responsivity, this hernia device is positioned fixation free within the defect and induces a probiotic biological response allowing for the re-establishment of the degenerated inguinal barrier. A laparoscopic approach with the 3D scaffold has been tested on 71 patients to demonstrate its effectiveness in reducing intra and postoperative complications. The operated patients presented with bilateral and/or recurrent inguinal hernia. Overall, 122 hernia defects were obliterated with 119 dynamic responsive scaffolds. The procedures were carried out from January 2018 to January 2022 with a defined protocol and detailed procedural steps. The laparoscopic technique with the 3D hernia scaffold allowed for fixation free placement, permanent defect obliteration and dynamically induced regenerative effects. The technique proved effective in reducing intra and postoperative complications. In particular, early postoperative pain and discomfort significantly decreased. No chronic pain and no recurrences were reported during follow up. The results achieved with the described laparoscopic technique seem to embody an innovative concept for inguinal hernia repair. Fixation free, dynamic responsive, permanent defect obliteration, histologically proven regenerative effects are the distinctive features of this 3D scaffold. It seems to embody a more physiological and pathogenetically coherent concept of cure, thus improving treatment results of this widespread disease.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor

Amato

Agrusa

Calò

et al. 2022

Sci Rep

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“…The investigation focused on individuals all diagnosed with primary uncomplicated inguinal protrusion who underwent hernia repair with the 3D dynamic responsive hernia scaffold ProFlor. ( Figure 1 A) The study utilizes the same tissue specimens used for other studies and excised from fifteen patients who underwent primary inguinal hernia repair in the period 2010–2015 and that, for different reasons, needed additional surgery for different reasons in the previously operated groin [ 17 , 18 , 19 , 20 , 21 , 22 ]. The mean age of the patients was 52 years, mean BMI 27.6.…”

Section: Methodsmentioning

confidence: 99%

“…Additional evidence of the dynamically induced regenerative features of ProFlor in patients has been confirmed by signal intensity assessment in MR imaging [ 20 ]. To further explain the regenerative features, a recent investigation has documented the involvement of vascular growth factors in modulating the probiotic response of these tissue components [ 21 ]. However, despite there being a solid neomyogenesis which has already been documented in ProFlor, knowledge is still lacking concerning the myogenic factors involved in neomyogenesis inside the 3D dynamic responsive hernia scaffold [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin

Amato

Rodolico

Puleio³

et al. 2022

JFB

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Background: Postoperative chronic pain caused by fixation and/or fibrotic incorporation of hernia meshes are the main concerns in inguinal herniorrhaphy. As inguinal hernia is a degenerative disease, logically the treatment should aim at stopping degeneration and activating regeneration. Unfortunately, in conventional prosthetic herniorrhaphy no relationship exists between pathogenesis and treatment. To overcome these incongruences, a 3D dynamic responsive multilamellar scaffold has been developed for fixation-free inguinal hernia repair. Made of polypropylene like conventional flat meshes, the dynamic behavior of the scaffold allows for the regeneration of all typical inguinal components: connective tissue, vessels, nerves, and myocytes. This investigation aims to demonstrate that, moving in tune with the groin, the 3D scaffold attracts myogenic growth factors activating the development of mature myocytes and, thus, re-establishing the herniated inguinal barrier. Methods: Biopsy samples excised from the 3D scaffold at different postoperative stages were stained with H&E and Azan–Mallory; immunohistochemistry for NGF and NGFR p75 was performed to verify the degree of involvement of muscular growth factors in the neomyogenesis. Results: Histological evidence of progressive muscle development and immunohistochemical proof of NFG and NFGRp75 contribution in neomyogenesis within the 3D scaffold was documented and statistically validated. Conclusion: The investigation appears to confirm that a 3D polypropylene scaffold designed to confer dynamic responsivity, unlike the fibrotic scar plate of static meshes, attracts myogenic growth factors turning the biological response into tissue regeneration. Newly developed muscles allow the scaffold to restore the integrity of the inguinal barrier.

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State of the Art and Future Perspectives in Inguinal Hernia Repair

Amato

2022

Inguinal Hernia: Pathophysiology and Genesis of the Disease

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Enhanced angiogenesis in the 3D dynamic responsive implant for inguinal hernia repair ProFlor

Cited by 8 publications

References 56 publications

Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor

Fixation free laparoscopic obliteration of inguinal hernia defects with the 3D dynamic responsive scaffold ProFlor

Dynamic Responsive Inguinal Scaffold Activates Myogenic Growth Factors Finalizing the Regeneration of the Herniated Groin

State of the Art and Future Perspectives in Inguinal Hernia Repair

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