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PhotoFix®

DECELLULARIZED BOVINE PERICARDIUM

Feel the Difference.

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Product Highlights

  • No aldehyde chemistry used in any part of the process.1
  • Nonimmunogenic, biocompatible, non-cytotoxic, and maintains natural physical properties and biomechanical integrity.2
  • Feels similar to autologous tissue, and is easy to trim, shape, and suture.1

Product Overview

Design Features
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1. NO ALDEHYDE CHEMISTRY

PhotoFix uses dye-mediated photo-oxidization to crosslink and stabilize the internal collagen structure – eliminating toxic by-products that create sites where calcium can bind to tissue.1-4

2. FEEL THE DIFFERENCE

Feels similar to Autologous tissue and is easy to trim and shape.

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3. RELIABLE STRENGTH

Strong, uniform, and easy to suture.

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4. READY TO USE

NO Rinsing, NO Rehydrating, and
NO Waiting.

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Clinical Evidence

USE OF PHOTOFIX IN CONGENITAL CARDIAC SURGERY AT BOSTON CHILDREN'S HOSPITAL1

  • 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.”1
    • “No calcification noted in 5 cases, mild calcification in 2 cases and at least moderate calcification in 1 case.”1

 

Click here to read the publication.

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PHOTO-OXIDIZED DECELLULARIZED BOVINE PERICARDIUM USED AS A PATCH IN VASCULAR REPAIR AND RECONSTRUCTION SURGERY2

  • A prospective, post-market study was performed of 94 patients that underwent a vascular procedure between 2018 and 2020.
  • A mean follow-up was performed at 187 days and was slightly higher for the PAD patients (193 days) than the CAS patients (186 days).
  • Primary Endpoints include (Figure 3):
    • Carotid Artery Stenosis (CAS) Patients (n=78) – Incidence of Ipsilateral Central Neurologic Events (2, 2.6%)
    •  Peripheral Arterial Disease (PAD) Patients (n=16) – Primary Patency Maintained (16, 100%)
  • Secondary Endpoints include Overall Survival (94, 100%),
    All-Cause Re-operation (1, 1.1%), Device-Related Re-operation (0, 0%), Explant (0, 0%), Restenosis > 50% in Target Artery (4, 4.3%)
  • This study provides the first published clinical data on the Photo-oxidized Bovine Pericardial Patch (pBPP) used within vascular indications. Vascular repair and reconstruction with a pBPP revealed promising early clinical outcomes with limited morbidity.
  • This study provides performance and safety data that supports the continued use of PhotoFix as a cardiovascular patch and provides distinction amongst other vascular patches, with low event rates.
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ANIMAL STUDIES HAVE SHOWN:

  • There was no evidence of collagen degradation, thrombogenicity, infection, excessive inflammation or intrinsic calcification in sheep animal models (140 days).3
  • PhotoFix process has demonstrated no significant calcification in both subcutaneous rat
    (60 days) implants and juvenile sheep (140 days) animal models.3
  • Endothelial cell growth is supported in vitro by photooxidized pericardium and vascular grafts (Figure 5).4  
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STRUCTURAL STRENGTH:

  • Comparison of biomechanical performance patches.
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Product Animation

Photo-Oxidization vs. Glutaraldehyde Fixation

Additional Resources

Explore additional resources for PhotoFix below. For further information or to contact a sales associate in your area, contact us.

OUS ORDERING
INFORMATION

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Product Highlights

  1. Artivion, Inc. Data on file.
  2. Schmidt C E, et. al. (2000). Acellular vascular tissues: Natural biomaterials for tissue repair and tissue engineering. Biomaterials, 21(22), 2215-2231.

Product Overview

  1. Schoen, F J, et. al. (2005). Calcification of tissue heart valve substitutes: progress toward understanding and prevention. Ann Thorac Surg, 79(3), 1072-1080.
  2. Umashankar P R, et. al. (2012). Glutaraldehyde treatment elicits toxic response compared to decellularization in bovine pericardium. Toxicol Int, 19(1), 51-58.
  3.  Golomb G, et. al. (1987). The role of glutaraldehyde-induced cross-links in calcification of bovine pericardium used in cardiac valve bioprostheses. Am J Pathol, 127(1), 122-130.
  4. Moore M A, et. al. (2001). Calcification resistance, biostability, and low immunogenic potential of porcine heart valves modified by dye-mediated photooxidation. J Biomed Mater Res, 56(1), 24-30.

 

Clinical Evidence

  1. Baird C, et. al. (2016). Photo-oxidized bovine pericardium in congenital cardiac surgery: single-centre experience. Interact Cardiovasc Thorac Surg, 24(2), 240-244.
  2. Morrissey, N. et. al. (2022). Post-market, Prospective Evaluation of Photo-oxidized Decellularized Bovine Pericardium Used as a Patch in Vascular Repair and Reconstruction Surgery: PHOTO-V.Vasc Dis Manag, 19(12), E182-E189
  3. Artivion, Inc. Pre-Clinical Data on File.
  4. Schmidt C E, et. al. (2000). Acellular vascular tissues: Natural biomaterials for tissue repair and tissue engineering. Biomaterials, 21(22), 2215-2231.
  5. Artivion, Inc. Data on file.

Refer to the device’s Instructions for Use for indications, contraindications, warnings, precautions, and possible complications. All products and indications are not available / approved in all markets. All trademarks are owned by Artivion, Inc. or its subsidiaries. © 2025 Artivion, Inc. All rights reserved. MWENG0065.000. (2025-10)

Artivion, Inc., 1655 Roberts Blvd NW, Kennesaw, GA 30144, US