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XenMatrix™ Biologic hernia grafts XenMatrix™ Surgical Graft

XenMatrix™ Surgical Graft, Rectangle, 6.3 in x 2.4 in (6 cm x 16 cm)

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 207 2. Mar: 255(3):595-60£..

Indications

XenMatrix™ Surgical Graft is intended for implantation to reinforce soft tissue defects where weakness exists in abdominal and incisional hernias.

Contraindications

1. XenMatrix™ Surgical Graft should not be used on patients with known sensitivity to porcine products.

2. Not for reconstruction of cardiovascular defects.

3. Not for reconstruction of central nervous system or peripheral nervous system defects.

4. Use of this product in applications other than those indicated has the potential for serious complications.

Warnings

1. This device has been designed for single use only. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/

or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may

result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause

patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination

of the device may lead to injury, illness or death of the patient or end user.

2. DO NOT RESTERILIZE

3. Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the package is

damaged or open, or if the center of the temperature indicator on the foil pouch is black.

4. If an infection develops, it should be treated aggressively.

5. An allergic reaction, which is unrelated to other therapy, is an indication to consider removal of XenMatrix™ Surgical Graft.

6. After use, any unused product and packaging should be treated as a potential biohazard. Handle and dispose of in accordance with accepted

medical practice and applicable local, state, and federal laws and regulations.

7. The safety and effectiveness of XenMatrix™ Surgical Graft in the following applications has not been evaluated or established:

a. Pregnant or breastfeeding women

b. Pediatric use

Precautions

1. Please read all instructions prior to use.

2. Only physicians qualified in the appropriate surgical techniques should use this surgical graft.

3. Strict aseptic technique should be followed.

4. U. S. federal law restricts this device to sale by or on the order of a physician.

5. The surgeon should thoroughly understand the surgical procedure and the performance characteristics of the surgical graft.

6. Place the graft in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling.

7. When unable to close the 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.

Adverse Reactions

Possible complications may include but are not limited to allergy, seroma, infection, inflammation, adhesion, fistula formation, hematoma, and

recurrence of the tissue defect.

 

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

BD-116774

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Specification

GTIN - Case

00801741074356

1


Quantity

1/cs


Dimensions

6.3" x 2.4" (6 cm x 16 cm) Rectangle

GTIN

GTIN - Case 00801741074356 1

Packaging

Quantity 1/cs

Product Basic Specification

Dimensions 6.3" x 2.4" (6 cm x 16 cm) Rectangle
References
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Electronic Instructions for Use (eIFUs)
Resources
References
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Frequently Asked Questions
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Related Products
RELATED PRODUCTS NOT AVAILABLE
References
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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
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