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:

  • Vascular repair and reconstruction
    • Carotid
    • Iliac
    • Femoral
    • Tibial blood vessels
    • Arteriovenous access revisions
  • Intracardiac repair
  • Great vessel repair
  • Suture line buttressing
  • Pericardial closure
PhotoFix is indicated for Use Vascular repair and reconstruction.
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 nonummunogenic, biocompatible, non-cyto-toxic, and maintains natural physical properties and bio-mechanical 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 Material9

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).9

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 US.

Catalog Number Description Size
PFP6X8 Decellularized Bovine
Pericardium Patch (Rectangle)
6 cm x 8 cm
PFP0.8X8 Decellularized Bovine
Pericardium Patch (Tapered end)
0.8 cm x 8 cm
PFP1X6 Decellularized Bovine
Pericardium Patch (Rounded ends)
1 cm x 6 cm
PFP2X9 PhotoFix® Decellularized Bovine Pericardium (Rounded) 2cm x 9cm
PFP1X10 PhotoFix® Decellularized Bovine Pericardium (Tapered) 1cm x 10cm
PFP1X14 PhotoFix® Decellularized Bovine Pericardium (Tapered) 1cm x 14cm

Speak with a specialist! 1.888.427.9654

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. Acellular vascular tissues_natural biomaterials for tissue repair and tissue engineering. Biomaterials 2000.
  6. Baird C. et al. Interactive CardioVascular and Thoracic Surgery. 2016; pii: ivw315.
  7. Majeed A. et al. Pediatric and Developmental Pathology. 2016; 19(5): 383-388.
  8. 510K Sheep Study, Data on file.
  9. Schmidt and Baier et.al.