Biologics
BIOTAPE XM® Reinforcement Matrix
Terminally Sterile Option for Soft-Tissue Augmentation
- Terminally sterile medical device
Storage at ambient temperatures under 99° F - Acellular porcine dermal matrix
Collagen scaffold is preserved intact during processing and is not chemically cross-linked - Distinct fibroblast infiltration
and revascularization - 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
BIOTAPE XM® Reinforcement Matrix prior to contact with human mesenchymal stem cells (hMSCs)
30 Minutes After Seeding hMSCs exhibit round morphology at this early time point on the BIOTAPE XM® Reinforcement Matrix
4 Hours After Seeding hMSCs assume flattened morphology as they adhere to the BIOTAPE XM® Reinforcement Matrix
3 Days After Seeding hMSCs completely flattened out indicating attachment to BIOTAPE XM® Reinforcement Matrix
* Qualitative evaluation using scanning electron microscopy (SEM)
In-vivo Canine Achilles Augmentation
Pre-Clinical: Six Weeks Post-op in a Canine Achilles Model
BIOTAPE XM® Matrix shows distinct incorporation, fibroblast infiltration, and revascularization throughout matrix at 6 weeks. Arrows indicate blood vessels.*
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.
Intra-op: BIOTAPE XM® material on-lay.
5 months post-op: BIOTAPE XM® material showing vascular ingrowth, incorporation, and lack of inflammatory response.
Clinical: Biopsy Taken 5 months Post-op in Achilles Repair
Longitudinal section of native tendon and an on-lay of BIOTAPE XM® Matrix.
The graft was populated with numerous blood vessels and fibroblasts. There were no inflammatory cells within or adjacent to the BIOTAPE XM® Matrix.
Time to Consider BIOTAPE XM® Reinforcement Matrix
* It is unknown how results from the canine model compare with clinical results in humans
** Individual results may vary. Not every individual will experience the same benefit.
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