Feel the Difference with PhotoFix Decellularized Bovine Pericardium

FEEL THE DIFFERENCE

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.

PhotoFix Technology

Indications for Use

PhotoFix is indicated for the following uses:

  • Intracardiac repair
  • Great vessel repair
  • Suture line buttressing
  • Pericardial closure
PhotoFix_AorticArch

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.

THE CLINICAL STORY

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

PhotoFix Actuarial Survival

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

Endothelial Cell Monolayers on Photooxidized Material

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 is currently only available in the United States & Europe

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

  1. Schoen FJ, et al. Ann Thorac Surg. 2005; 79:1072-1080.
  2. Umashankar PR, et al. Toxicol Intl. 2012; 19(1):51-58.
  3. Golomb G, et al. Am J Pathol. 1987; 127:122-130.
  4. Moore MA, et al. J Biomed Mater Res. 2001; 56(1):24-30.
  5. Schmidt CE, Baier JM. Biomaterials. 2000 Nov;21(22):2215-31.
  6. Baird C. et al. Interactive CardioVascular and Thoracic Surgery.2017;24(2):240-244.
  7. Majeed A. et al. Pediatric and Developmental Pathology. 2016; 19(5): 383-388.
  8. Pre-Clinical Data on file.

MLENG1317.000 (2018-10)

photofix-ce-mark-2018