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| BIOTAPE XM™ Reinforcement Matrix |
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Terminally Sterile Option for Soft-Tissue Augmentation
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Terminally sterile medical device
Storage at ambient temperatures under 99° F
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Acellular porcine dermal matrix
Collagen scaffold is preserved intact during processing and is not chemically cross-linked
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Distinct fibroblast infiltration
and revascularization
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Incorporates with host tissue
Time to Consider Strength
*Seven matched human cadaver PTT tendon pairs were harvested and surgically transversely cut to simulate a mid-section tendon rupture. Tendons were primarily repaired or primarily repaired and augmented with the BIOTAPE XM™ Matrix. Constructs were pre-loaded for 60 seconds and pre-conditioned for 30 seconds before loading to failure at a rate of 1mm/sec. Additional testing details on file.
Time to Consider Biology
Stem Cell Seeding
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BIOTAPE XM™ Reinforcement Matrix prior to contact with human mesenchymal stem cells (hMSCs)
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30 Minutes After Seeding
hMSCs exhibit round morphology at this early time point on the BIOTAPE XM™ Reinforcement Matrix
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4 Hours After Seeding
hMSCs assume flattened morphology as they adhere to the BIOTAPE XM™ Reinforcement Matrix
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3 Days After Seeding
hMSCs completely
flattened out indicating
attachment to BIOTAPE XM™ Reinforcement Matrix
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| * Qualitative evaluation using scanning electron microscopy (SEM)
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In-vivo Canine Achilles Augmentation
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Pre-Clinical: Six Weeks Post-op in a Canine Achilles Model
BIOTAPE XM™ Matrix shows distinct fibroblast incorporation, fibroblast infiltration, and revascularization throughout matrix at 6 weeks. Arrows indicate blood vessels.
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Clinical Histology Case Study
- Achilles tendon primary repair with BIOTAPE XM™ on-lay
- Several months post-operatively the patient fell off her bicycle, re-rupturing the tendon at a location different than the original tear. Revison surgery occured at 5 months.
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Intra-op: BIOTAPE XM™
material on-lay.
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5 months post-op: BIOTAPE XM™ material showing vascular ingrowth, incorporation, and lack of inflammatory response.
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Clinical: Biopsy Taken 5 months Post-op in Achilles Repair
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Longitudinal section of native tendon and an on-lay of BIOTAPE XM™ Matrix. There was extensive incorporation between the graft and the native tendon.
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The graft was populated with numerous blood vessels and fibroblasts. There were no inflammatory cells within or adjacent to the BIOTAPE XM™ Matrix.
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Time to Consider BIOTAPE XM™ Reinforcement Matrix
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