Photo-oxidation vs. Glutaraldehyde Fixation
Watch a short animated video to learn more about the photo-oxidation process, and how it is different from glutaraldehyde fixation.
Glutaraldehyde Fixation vs. Photo-Fixation
Unlike glutaraldehyde treated tissue, PhotoFix tissue uses dye-mediated photo-oxidation to crosslink and stabilize the internal collagen structure - eliminating toxic by-products that create sites where calcium can bind to tissue.1-4
PhotoFix is nonimmunogenic, biocompatible, non-cytotoxic, and maintains natural physical properties and biomechanical integrity.5
Refer to Instructions for Use for complete product information.
Use of PhotoFix in Congenital Cardiac Surgery at Boston Children's Hospital6
- 490 patches used between 2008 and 2011 in 364 patients (median age 5.3 years).
- Mean late follow-up of 3.2±1.6 years.
- Demonstrated excellent performance in cardiovascular repair in children.
- Wide range of applications show consistent handling characteristics and biocompatibility.
- Eight patch specimens were available for histological analysis (up to 72 months):
- “Inflammation was absent or minimal in 6 cases and mild in 2 others.”6
- “No calcification noted in 5 cases, mild calcification in 2 cases and at least moderate calcification in
1 case.”6
Figure 1: Actuarial Survival6
Review of clinical and pathology database of patches used in cardiac surgery at one children's hospital noted:7
- PhotoFix used in locations exposed to lower stresses showed little or no calcification.
- Calcification did not differ significantly between PhotoFix and autologous pericardium in multiple intracardiac applications.
- The grades of neointima formation did not demonstrate a significant difference between PhotoFix and autologous pericardium.
Figure 2: Endothelial Cell Monolayers on Photooxidized Material5
Animal studies have shown:
- There was no evidence of collagen degradation, thrombogenicity, infection, excessive inflammation or intrinsic calcification in sheep animal models (140 days).8
- PhotoFix process has demonstrated no significant calcification in both subcutaneous rat (60 days) implants and juvenile sheep (140 days) animal models.8
- Endothelial cell growth is supported in vitro by photooxidized pericardium and vascular grafts (Figure 2).5
How Supplied
PhotoFix is supplied sterile and non-pyrogenic in a sealed container with 22% buffered ethanol solution.
Ordering Information
PhotoFix Sizes Available with CE Mark
| PFP6X8-G | Decellularized Bovine Pericardium Patch (Rectangle) | 6 cm x 8 cm |
| PFP4X4-G | Decellularized Bovine Pericardium Patch (Square) | 4 cm x 4 cm |
| PFP0.8X8-G | Decellularized Bovine Pericardium Patch (Tapered end) | 0.8 cm x 8 cm |
| PFP1X6-G | Decellularized Bovine Pericardium Patch (Rounded ends) | 1 cm x 6 cm |
References
- Schoen FJ, et al. Ann Thorac Surg. 2005; 79:1072-1080.
- Umashankar PR, et al. Toxicol Intl. 2012; 19(1):51-58.
- Golomb G, et al. Am J Pathol. 1987; 127:122-130.
- Moore MA, et al. J Biomed Mater Res. 2001; 56(1):24-30.
- Schmidt CE, Baier JM. Biomaterials. 2000 Nov;21(22):2215-31.
- Baird C. et al. Interactive CardioVascular and Thoracic Surgery.2017;24(2):240-244.
- Majeed A. et al. Pediatric and Developmental Pathology. 2016; 19(5): 383-388.
- Pre-Clinical Data on file.
MLENG1317.000 (2018-10)
