Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review

Speed, Olivia; Bareiss, Anna K.; Patel, Vijay A.; Mangan, Andrew; Dornhoffer, John L.; Saadi, Robert

doi:10.1016/j.amjoto.2023.103961

Cited by 5 publications

(3 citation statements)

References 9 publications

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“…As highlighted earlier, the effective employment of SIS biological scaffolds across multiple research domains has laid the groundwork for its application in clinical therapies. To date, SIS has achieved considerable progress in treating conditions such as abdominal hernias, full-thickness skin defects, bladder and vaginal defects, and eardrum repairs [ [150] , [151] , [152] , [153] , [154] ]. These clinical applications have yielded impressive results.…”

Section: Clinical Applications Of Sismentioning

confidence: 99%

The application of small intestinal submucosa in tissue regeneration

Zhao,

Peng,

Sun

et al. 2024

Materials Today Bio

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Section: Clinical Applications Of Sismentioning

confidence: 99%

The application of small intestinal submucosa in tissue regeneration

Zhao,

Peng,

Sun

et al. 2024

Materials Today Bio

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“…4 Other studies also mention underreporting or reporting bias as a concern. [5][6][7][8] In some studies, there may be a heavy skew towards reports submitted by mandatory reporters compared to voluntary reporters. 6 The "incomplete, inaccurate, or biased data" inherent to the MAUDE database limits a thorough understanding of adverse events associated with medical devices.…”

Section: Commentarymentioning

confidence: 99%

Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Batheja,

Bentan,

Coelho

2024

Otolaryngol.--head neck surg.

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The use of the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) to analyze adverse events linked to medical devices has grown in recent years. MAUDE facilitates post‐market surveillance, contributing to the assessment of device performance and the identification of potential safety concerns. The database is instrumental not only for mandatory reporters such as manufacturers and healthcare facilities but also offers a platform for voluntary submissions from clinicians and patients, thus widening the scope of data collection. While the database offers valuable data, there are important limitations that must be understood in order to encourage appropriate interpretation of findings. This commentary highlights the major advantages and disadvantages of the MAUDE database, as well as describes possible areas for improvement in adverse event reporting.

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“…small intestinal submucosa (SIS) is commonly used in cartilage tissue engineering to enhance the bioactivity of scaffolds, due to the following reasons: (i) the SIS is rich in various bioactive substances, such as growth factors, cytokines and collagen, among others. These substances can be released from the scaffold, promoting cell proliferation and differentiation, thus facilitating cartilage tissue generation and regeneration [ 26 ]. (ii) SIS possesses a native cell-adhesive structure, facilitating cell attachment and growth.…”

Section: Introductionmentioning

confidence: 99%

Enhancing cartilage regeneration and repair through bioactive and biomechanical modification of 3D acellular dermal matrix

Gao,

Cheng,

Tang

et al. 2024

Regenerative Biomaterials

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Acellular dermal matrix (ADM) shows promise for cartilage regeneration and repair. However, an effective decellularization technique that removes cellular components while preserving the extracellular matrix, the transformation of 2D-ADM into a suitable 3D scaffold with porosity, and the enhancement of bioactive and biomechanical properties in the 3D-ADM scaffold are yet to be fully addressed. In this study, we present an innovative decellularization method involving 0.125% trypsin and 0.5% SDS and a 1% Triton X-100 solution for preparing ADM and converting 2D-ADM into 3D-ADM scaffolds. These scaffolds exhibit favorable physicochemical properties, exceptional biocompatibility, and significant potential for driving cartilage regeneration in vitro and in vivo. To further enhance the cartilage regeneration potential of 3D-ADM scaffolds, we incorporated porcine-derived small intestinal submucosa (SIS) for bioactivity and calcium sulfate hemihydrate (CSH) for biomechanical reinforcement. The resulting 3D-ADM+SIS scaffolds displayed heightened biological activity, while the 3D-ADM+CSH scaffolds notably bolstered biomechanical strength. Both scaffold types showed promise for cartilage regeneration and repair in vitro and in vivo, with considerable improvements observed in repairing cartilage defects within a rabbit articular cartilage model. In summary, this research introduces a versatile 3D-ADM scaffold with customizable bioactive and biomechanical properties, poised to revolutionize the field of cartilage regeneration.

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Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review

Cited by 5 publications

References 9 publications

The application of small intestinal submucosa in tissue regeneration

The application of small intestinal submucosa in tissue regeneration

Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Enhancing cartilage regeneration and repair through bioactive and biomechanical modification of 3D acellular dermal matrix

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