Biologic Solution for Neonatal & Infant CV Repair.

Our 2-ply extracellular matrix patch is the only one of its kind available. An ECM derived from porcine small intestine submucosa (SIS), Tyke regulates the biologic healing response to decrease inflammation and stimulate formation of healthy tissue.2,4,9,10 Tyke was specifically designed for neonatal and infant cardiovascular repair.1 Our goal is to provide a solution for pediatric surgeons that is pliable, strong, resistant to calcification, and is ideal for long-term repairs.

A Pediatric Surgeon checking on a child in the hospital

Reduce Risk. Naturally.

We Help Pediatric Heart Surgeons Repair Small and Fragile Tissue.

Our porcine derived matrix (SIS ECM) designed for neonatal and pediatric surgery helps mitigate excessive scar tissue formation, calcification, and have demonstrated an ability to grow with the surrounding tissue.2,3

“The host response to biomaterials is a critical determinant of their success or failure in tissue-repair applications.”

Dziki JL, et al. J Biomed Mater Res A. 2017;105(1):138–147.

How Aziyo Helps.

Stephen F. Badylak, DVM, PhD, MD
Deputy Director, McGowan Institute for Regenerative Medicine, University of Pittsburgh

ECM Regulates Healing

When sutured next to viable tissue, Aziyo surgical products have a potential to remodel into site specific tissue.2,4,9,10 An advantage is that should you ever need to redo the procedure, you would perform surgery on tissue with the same properties as the surrounding native tissue.3 For neonates and infants, we offer a biologic solution that is strong, pliable, resistant to calcification, and reduces post-operative inflammation.2,3 Lastly, during remodeling, SIS ECM, releases antimicrobial peptides, and stimulates angiogenesis.2,4,9,10 Learn how SIS ECM reduces inflammation and regulates the healing response from tissue engineering expert Dr. Badylak.

ECM. How It Works.

The Body’s Reaction 

When you implant a device or foreign material in a patient, their immune response either integrates and remodels it into healthy tissue or induces prolonged inflammation and eventual formation of fibrotic tissue. While we all work towards the former, the latter is far too common.

Stephen F. Badylak, DVM, PhD, MD
Deputy Director, McGowan Institute for Regenerative Medicine, University of Pittsburgh

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Minimize Inflammation

To minimize inflammation (and the associated complications) and achieve optimal tissue remodeling outcomes in patients, we’ve constructed Tyke using multilaminate sheets of decellularized, non-crosslinked, lyophilized (SIS).

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Healthy Tissue Growth

SIS derived Extracellular Matrix (ECM) is a biomaterial rich in growth factors and structural proteins.4,9,10 Useful in multiple applications, SIS remodels into healthy, site-specific tissue that stimulates healthy tissue growth and inhibits excessive scarring.2,3,4,9,10

Phases of ECM Guided Wound Healing.

An image that shows cellular inflammation

Inflammation

Inflammation involving M1 macrophages is an inherent component of healing. However, prolonged M1 macrophage function can cause chronic inflammation and lead to fibrosis and scarring. The presence of SIS ECM promotes a shift from M1 to a pro-remodeling, anti-inflammatory M2 phenotype.6

An image showing proliferation in the body

Proliferation

Concurrent with the inflammatory phase, in the proliferation phase fibroblasts populate the SIS ECM through attaching and proliferating.7 This stage is also marked by angiogenesis and epithelization which forms healthy vascularized tissue.7 

An image of remodeling within the body

Tissue Remodeling

As the SIS ECM is broken down and absorbed, the number of fibroblasts and macrophages in the matrix declines over time.7 Matrix turnover ultimately slows and eventually stops, ending angiogenesis.6 Scaffold remodeling is complete when metabolic activity stabilizes and the newly regenerated tissue becomes fully functional.7,8

Learn About Tyke.

The natural choice in neonatal and infant cardiovascular repair.

Tyke is used for neonatal and infant patch, pledget, and intracardiac repair, and provides a natural extracellular matrix bioscaffold that promotes regeneration of the patient’s own cells to form healthy, site-specific tissue.

A baby having their heart monitored by a CV Surgeon

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1. Aziyo Biologics Data on File
2. Based on pre-clinical data on file.
3. Scholl FG, et al. World J Pediatr Congenit Heart Surg. 2010;1(1):132-136.
4. Dziki JL, et al. J Biomed Mater Res A. 2017;105(1):138–147.
5. Maxson, S., et al., Stem Cells Transl Med, 2012. 1(2): p. 142-9.
6. Lech, M., et al. Biochim Biophys Acta, 2013. 1832(7): p. 989-97.
7. Savill, J., et al. J Leukoc Biol, 1997. 61(4): p. 375-80
8. Velnar T., et al. J Int Med Res, 2009. 37(5): p. 1528-42.
9. Badylak S et al. J Surg Res. 2002 Apr;103(2):190-202.
10. Brennan EP, et al. Tissue Eng. 2006;12(10):2949-2955. doi:10.1089/ten.2006.12.2949

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