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XenMatrix™ Biologic hernia grafts XenMatrix™ Surgical Graft
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Overview

Confidence Reinforced

XenMatrix™ Grafts are created using the patented AquaPure™ Process which effectively removes cells while maintaining the structure and strength of the graft. The resulting open collagen scaffold allows early cellular infiltration and revascularization without a significant loss of strength during the early healing process as demonstrated in preclinical studies.1

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Features and Benefits
Promotional Story
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References

1. Preclinical data on file, results may not correlate to clinical performance

2. Deeken CR, Eliason B, Pichert M, Grant S, Frisella M, Matthews B. Differentiation of Biologic Scaffold Materials Through Physiomechanical, Thermal and Enzymatic Degradation Techniques. Ann Surg 2012. Mar; 255(3):595-604.

Indications

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Contraindications

XenMatrix™Surgical Graft should not be used on patients with known sensitivity to porcine products. Not for reconstruction of cardiovascular defects. Not for reconstruction of central nervous system or peripheral nervous system defects. Use of this product in applications other than those indicated has the potential for serious complications.

Warnings

If an infection develops, it should be treated aggressively. An allergic reaction, which is unrelated to other therapy, is an indication to consider removal of XenMatrix™ Surgical Graft.

Precautions

Place device in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. When unable to close skin over the XenMatrix™ Surgical Graft, ensure that the implant remains moist. Avoid drying of the implant through “continued suction devices” as this may negatively impact the performance of the implant. Only physicians qualified in the appropriate surgical techniques should use this surgical graft. The surgeon should thoroughly understand the surgical procedure and the performance characteristics of the surgical graft.

Adverse Reactions

Potential complications with the use of any prosthesis may include, but are not limited to, allergy, seroma, infection, inflammation, adhesion, fistula formation, hematoma and recurrence of tissue defect.

Please consult package insert for more detailed safety information and instructions for use.

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Specification

GTIN - Case

00801741031458

1


Quantity

1/cs


Dimensions

7.9” x 7.9” (20 cm x 20 cm) Square

GTIN

GTIN - Case 00801741031458 1

Packaging

Quantity 1/cs

Product Basic Specification

Dimensions 7.9” x 7.9” (20 cm x 20 cm) Square
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Resources
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Frequently Asked Questions
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Related Products
RELATED PRODUCTS NOT AVAILABLE
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
information quickly and effectively, please contact our customer complaints
team.

To better facilitate our investigation, please include the following information in your reporting:


  • Product Name and/or Catalog Number
  • Lot Number or Serial Number
  • Any injuries and/or Harm?
  • What is the issue you experienced?
  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
Product Recalls
Recall Notifications
These recall notices provide current information on medical device recalls.
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