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STRATTICE™ Reconstructive Tissue Matrix


STRATTICE™ Tissue Matrix
STRATTICE™ Tissue Matrix
STRATTICE™ Tissue Matrix
STRATTICE™ Tissue Matrix
STRATTICE™ Tissue Matrix
STRATTICE™ Tissue Matrix

STRATTICE™ Reconstructive Tissue Matrix: The Most Clinically-Studied Biological Matrix*

This product is commercialized by LifeCell Corporation, which has been acquired by Allergan. For more information, please contact LifeCell at (800) 367-5737.
 
Surgeons around the world choose STRATTICE™ Reconstructive Tissue Matrix (RTM) for reconstructive surgery because it regenerates into the patient’s own tissue and may lead to desired outcomes.**
 
What differentiates STRATTICE™ RTM from competitors is our proprietary processing method, which retains biochemical components and collagen structure to support regeneration.**12
 
* Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in June 2016.
** Correlation of these results to results in humans is not established.
 

Overview

Regenerative

Pre-clinical studies have shown STRATTICE™ RTM regenerates into the recipient's own tissue through cell repopulation, white cell migration, and rapid revascularization.**2
 
** Correlation of these results to results in humans is not established.

Clinically Proven

Reported in more than 90 peer-reviewed articles across 2,000 hernia patients*,
 
STRATTICE™ RTM has shown low rates of postoperative complications.
 
*Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in June 2016.

STRATTICE™ Replacement Guarantee

The STRATTICE™ Replacement Guarantee program offers a replacement of any piece of STRATTICE™ RTM when it has been used specifically for abdominal wall reconstructive applications at participating facilities.
 
Subject to terms and conditions, Acelity will replace STRATTICE™ RTM purchased and explanted by the participating facility.
 

How it Works

  • Overview
  • Mechanism of Action
  • FAQs
  • Materials For Download

Overview

Not All Biological Meshes Are Created Equal**1

Some processing can damage or alter the tissue matrix, which may impact how the body responds to a surgical mesh.**2 The LifeCell process is gentle, minimizing damage to the tissue matrix.
 
Minimizes Damage to the Matrix
  •  Proprietary LifeCell process
 
Retains Collagen Organization and Structure
  •  Proprietary LifeCell process
 
Promotes Tissue Regeneration
  • Cell repopulation (including fibroblast repopulation)
  • White cell migration
  • Rapid revascularization
  • Regenerates into recipient's own tissue

** Correlation of these results to results in humans is not established.
 

Mechanism of Action

Mechanism of Action
 

STRATTICE™ RTM is designed to reinforce tissue where weakness exists.
 
LifeCell carefully selects the tissue suitable for STRATTICE RTM. The tissue then goes through the LifeCell proprietary tissue process, which significantly reduces the components responsible for inflammation, allowing for positive recognition of the tissue matrix by the recipient.2 Key components of the matrix are preserved by a patented solution in order to be an effective platform for tissue regeneration. Finally, the matrix is then sterilized for patient safety.
 
The LifeCell process minimizes damage to the tissue matrix in order to support tissue regeneration and retain the tissue’s native properties out of package.**2 As shown in an animal model, this proprietary process allows for cell repopulation, rapid revascularization, and white cell migration, which may lead to increased resistance to infection at the surgical site.**3
 
** Correlation of these results to results in humans is not established.

FAQs

Technical FAQs

How do I prepare STRATTICE™ RTM for use?

Using aseptic technique, remove STRATTICE™ RTM from its packaging and immediately soak for 2 minutes in a sterile basin with room temperature sterile saline or sterile-lactated Ringer’s solution. Make sure the mesh is completely covered, and store at room temperature until ready for implantation. STRATTICE™ RTM can be kept in this ready-to-use state for up to 4 hours.

 

How do I use STRATTICE™ RTM in a surgical procedure?

STRATTICE™ RTM may be folded, trimmed, or cut to fit the surgical site. Place in maximum possible contact with healthy, well-vascularized tissue to promote cell growth and tissue regeneration. Handle with gloved hands or forceps and suture into place.

 

For what procedures is STRATTICE™ RTM recommended?

STRATTICE™ RTM is most often used in abdominal wall reconstruction surgeries.  Please see the STRATTICE ™ RTM Instructions for Use for more details.

 

In what sizes and shapes is STRATTICE™ RTM sold?

Please see the Ordering tab for sizes, shapes, and product codes. 

 

Indications & Applications

Indications & Applications

  • Overview
  • For Abdominal Wall Repair
  • For Parastomal Hernia Repair
  • For Inguinal Hernia Repair

Indications for Use

Before use, physicians should review complete risk information and essential prescribing information which can be found in the Instructions for Use
 
INDICATIONS FOR USE
STRATTICE™ TM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. 
STRATTICE™ TM is intended for single patient one-time use only.
 
CONTRAINDICATIONS
  • This device is derived from a porcine source and should not be used in patients with known sensitivity to porcine material. 
  • This device contains Polysorbate 20.
 
WARNING
  • Do not resterilize. Discard all open and unused portions of the device.
  • Do not use if the package is opened or damaged. Do not use if seal is broken or compromised.
  • After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
     
PRECAUTIONS
  • Discard device if mishandling has caused possible damage or
  • contamination, or the device is past its expiration date.
  • Soak the device for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the mesh.
  • Place device in maximum possible contact with healthy, well-vascularized
  • tissue to promote cell ingrowth and tissue remodeling.
  • STRATTICE™ TM should be hydrated and moist when the package is opened. If STRATTICE™ TM is dry, do not use.

For Abdominal Wall Repair

If a patient with synthetic mesh develops a postoperative wound complication, it is a serious problem that often leads to mesh removal. The removal of infected mesh is costly and may have tremendous impact on the patient’s quality of life.
 
STRATTICE™ RTM is a biological tissue matrix for hernia repair. The LifeCell Tissue Process retains the critical biochemical and biomechanical integrity of the tissue, which is essential for regeneration.2, STRATTICE RTM is a leader in the industry with more than 2,000 patients studied and less than 0.3% average explantation rate reported in all peer-reviewed Complex AWR publications tracking explantations.*,
 
* Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in June 2016.
†Each study was considered independent during calculation. Studies may contain overlapping patient populations. Percentage based on weighted average.
‡Correlation of these results to results in humans has not been established.

For Parastomal Hernia Repair

Parastomal hernia repairs are among the most challenging of hernia repair procedures. Postoperative infection is one of the most common complications.
 
Hernia recurrence is also a common complication. There is up to an 86% recurrence rate for stoma relocation.4
 
STRATTICE™ RTM and STRATTICE™ RTM Laparoscopic have been shown to be compatible with both the Keyhole and Sugarbaker techniques. Early white cell migration, cell repopulation and rapid revascularization has been shown in an animal study, which may lead to increased resistance to infection at the surgical site.**1
 
** Correlation of these results to results in humans is not established.

For Inguinal Hernia Repair

There are approximately 800,000 inguinal hernias reported each year.5 In a long-term, randomized multicenter clinical trial, STRATTICE™ RTM was shown to have low recurrence rates similar to polypropylene synthetic mesh.6 However, for some patients, synthetic mesh may not be appropriate. STRATTICE™ RTM is a biological alternative.
 

Evidence & Outcomes

STRATTICE™ RTM has been successfully used worldwide in thousands of plastic surgery and abdominal wall reconstruction procedures.
 

Clinical Evidence

Additional summary of evidence and outcomes.

Evidence & Outcomes

Product Evidence and Outcomes

Title Study Type Date Authors