10 Things to Know About Gentrix® Surgical Matrix

A 66-year-old male patient with a history of ventral hernia, diabetes, and hypertension presents with lateral side pain. A CT scan reveals a recurrent ventral hernia (Grade 3) of the upper abdomen, measuring approximately 10 cm x 5 cm.

What options would you consider to reinforce this abdominal wall defect?

Dr. Alvaro Garcia chose to use a 20 x 25 cm Gentrix® Surgical Matrix Thick device.

Gentrix, a fully resorbable biologically-derived device, is intended for the repair and reinforcement of complex hernia repairs, including ventral hernias. ^1–4It facilitates a remodeling process by the body that leads to the formation of site-appropriate tissue, while gradually being fully resorbed by the body.

Here are 10 things to know about Gentrix:

1. Remodeled tissue resembles native fascia. In a preclinical ovine study, the remodeling response to Gentrix was compared to that of Strattice™. At 3 months, the Gentrix device had been fully remodeled with deposition of site-appropriate connective tissue at the site, while the Strattice™ device was easily identifiable from surrounding tissue.^1–4,т The newly deposited tissue resembled the native surrounding tissue in terms of organization and mechanical properties.^1,5
2. Gentrix supports the body’s ability to deposit vascular, organized connective tissue with biomechanical properties akin to native tissue.³ In a preclinical porcine ventral hernia study, animals reinforced with Gentrix devices were associated with a positive tissue remodeling response.[1]^,т The remodeled tissue largely resembled the thickened posterior fascia of uninjured tissue.[2]
3. It has evidence of positive outcomes with minimal complications.[3] Gentrix is backed by clinical data demonstrating positive outcomes that allow patients to resume their normal daily activities. One study of complex patients showed minimal complications after using Gentrix and with long-term median follow-up of 36 months.⁵

• • 15.6% recurrence rate
  • 20% major wound care
  • No cases of erosion, fistulation, or bowel obstruction

4. It can be used to repair multiple types of hernias. Configurations of Gentrix are intended to be used for complex repairs, including ventral, incisional, parastomal, and hiatal hernias.
5. It’s easy to handle. Gentrix is designed for the repair and reinforcement of complex hernia repairs in both open and laparoscopic procedures. The flexible design allows the user to easily handle, place and secure the device even in laparoscopic procedures.[4]^-7
6. Gentrix is an open, porous scaffold composed of porcine urinary bladder matrix (UBM) and has been in use for more than 10 years.
7. It is made up of two distinct layers. One is a smooth epithelial basement membrane, which can contribute to cell attachment and proliferation, and the other is an open, porous lamina propria, which is conducive to integration of host connective tissue into the scaffold.
8. Gentrix is available in multiple layering configurations. Sizes ranging from 5×5 cm up to 30×40 cm. It also features a pre-cut, U-shaped graft specific for hiatal hernia repair.
9. It is designed to approximate the strength and stiffness of native tissue. Gentrix is specifically designed to approximate the strength and stiffness of native fascia both at time of implantation and after the graft resorbs.[5]
10. It contains no detergents or harsh chemicals. Gentrix processing does not incorporate detergents or other harsh chemicals that may lead to damage or crosslinking of the product.

Gentrix® Surgical Matrix

Gentrix® Surgical Matrix Hiatal

Gentrix® Surgical Matrix Plus

Indications

Gentrix Surgical Matrix, Gentrix® Surgical Matrix Hiatal, Gentrix® Surgical Matrix Plus are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia (e.g. hiatal/ diaphragmatic) and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. Gentrix® Surgical Matrix, Gentrix® Surgical Matrix Hiatal, Gentrix® Surgical Matrix Plus minimize tissue attachment to the device in case of direct contact with viscera.

Contraindications

Patients with known sensitivity or allergy to porcine materials.

Warnings:

• Device is not intended for transvaginal placement or treatment for pelvic organ prolapse or stress urinary incontinence.
• Device is not intended for bridging hernia defects.
• Exposure to contaminated or infected field can lead to weakening or breakdown of device.
• If active infection is present, treat patient to resolve infection prior to device implantation.
• Do not use if cracked, broken, or otherwise damaged.

Precautions:

• Always use aseptic technique when handling device.
• No studies have evaluated reproductive impact of clinical use of device.

Gentrix® Surgical Matrix Thick

Indications

Gentrix® Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Contraindications

Patients with known sensitivity or allergy to porcine materials.

Warnings:

• Device is not intended for transvaginal placement or treatment for pelvic organ prolapse or stress urinary incontinence.
• Device is not intended for bridging abdominal wall defects.
• Exposure to contaminated or infected field can lead to weakening or breakdown of device.
• If active infection is present, treat patient to resolve infection prior to device implantation.
• Do not use if cracked, broken, or otherwise damaged.

Precautions:

• Always use aseptic technique when handling device.
• No studies have evaluated reproductive impact of clinical use of device.
• Insertion of device through a trocar is not recommended.

Gentrix® Surgical Matrix Thin

Indications

Gentrix Surgical Matrix Thin is intended or implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. Gentrix Surgical Matrix Thin minimizes tissue attachment to the device in case of direct contact with viscera.

Contraindications

Patients with known sensitivity or allergy to porcine materials.

Warnings:

• Device is not intended for transvaginal placement or treatment for pelvic organ prolapse or stress urinary incontinence, bladder support, transabdominal sacrocolposuspension, reconstruction of the pelvic floor, or pubourethral support as device has not been evaluated for these indications and may not provide sufficient support.
• Do not use for high stress applications, such as large, high tension ventral hernias, repair of pelvic organ prolapse, and sacrocolposuspension as the device may not provide sufficient support.
• Device is not intended for bridging hernia defects.
• Exposure to contaminated or infected field can lead to weakening or breakdown of device.
• If active infection is present, treat patient to resolve infection prior to device implantation.
• Do not use if cracked, broken, or otherwise damaged.

Precautions:

• Always use aseptic technique when handling device.
• No studies have evaluated reproductive impact of clinical use of device.

[1] Brown BN, et al. Acta Biomaterialia. 2012;8(3):978-987

[2] Young DA, et al. Regenerative Medicine.2018; doi:10.2217/rme-2018-0023

[3] Sasse KC, et al. Hernia. 2018; doi:10.1007/s10029-018-1830-0

[4] Mehta, A., Afshar, R., Warner, D. L., Gardner, A., Ackerman, E., Brandt, J., & Sasse, K. C. (2017). Laparoscopic Rectopexy with Urinary Bladder Xenograft Reinforcement. JSLS : Journal of the Society of Laparoendoscopic Surgeons, 21(1), eJSLS.2016.00106. https://doi.org/10.4293/JSLS.2016.00106..

[5] Young DA, et al. Regenerative medicine. 2018; doi:10.2217/rme-2018-0091

^тAnimal model results do not necessarily translate to clinical results.

Gentrix is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

*The case is taken from Dr. Garcia’s clinical experience with the Gentrix® Surgical Matrix device. The decisions made in this case represent his professional judgment in patient care. Integra does not provide medical advice/recommendations.