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ALLODERM SELECT™ Regenerative Tissue Matrix


ALLODERM SELECT™ Tissue Matrix
ALLODERM SELECT™ Tissue Matrix
ALLODERM SELECT™ Tissue Matrix Contour
ALLODERM SELECT™ Tissue Matrix Contour

Introducing ALLODERM SELECT™ Regenerative Tissue Matrix – The Surgeons' Choice, Now with Enhanced Precision
 

This product is commercialized by LifeCell Corporation, which has been acquired by Allergan. For more information, please contact LifeCell at (800) 367-5737.
 
ALLODERM SELECT™ Regenerative Tissue Matrix is donated human dermis, processed to remove cells while preserving the essential biological components and structure of the dermal matrix to support regeneration. 
 
Our gentle processing allows ALLODERM SELECT™ Tissue Matrix to support rapid revascularization, cell repopulation, and white cell migration, as shown in an animal study, offering surgeons a natural solution for soft tissue support where weakness exists.1*
 
*Correlation of these results to results in humans has not been established.
 

Overview

Over 20 Years of Success

Surgeons have counted on ALLODERM™ Regenerative Tissue Matrix precision for over 20 years and LifeCell continues to shape the acellular dermal matrix market with precise attention to detail.
 
The ALLODERM™ RTM portfolio is the leading biological tissue matrix for breast reconstruction procedures.
 
ALLODERM™ RTM has the most extensive coding, coverage and reimbursement in breast reconstruction.**23
 
There have been more than 1 million grafts implanted to date, with ZERO documented cases of disease transmission.**
 

** Data on file
 

ALLODERM SELECT™ Tissue Matrix

The performance you expect with ALLODERM™ RTM, made with enhanced precision.
 
  • Desired biological response and handling
  • Precisely consistent shape
  • More thickness options (Thin, Medium, Thick, X-Thick)
  • Precise packaging for a smoother, straighter shape every time

ALLODERM SELECT DUO™ Tissue Matrix Bilateral Pair

 
Two matched pieces of ALLODERM SELECT™
Regenerative Tissue Matrix for bilateral
breast reconstruction.

 
  • Same donor, same shape, same thickness to offer uniform tissue characteristics for a consistent product experience
  • Purposeful packaging offers a smooth and straight product out of the package every time
  • Advanced cutting technology offers precise shapes and more thickness options to meet your patients’ needs
 

How it Works

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

Overview

Human Dermal Matrix: Changing the Quality of Soft Tissue Repair

ALLODERM SELECT Tissue Matrix is an acellular human dermal matrix, gently processed from donated and carefully screened human tissue. When sutured into the breast pocket, it readily incorporates with the patient’s own tissue. This allows for rapid revascularization, as well as minimal inflammation and scarring.*,**
ALLODERM SELECT Tissue Matrix provides natural, soft tissue support:
 
  • A preserved and undamaged acellular dermal matrix incorporates rapidly with the recipient’s own tissue2*
  • Allows for rapid revascularization, white cell migration, and repopulation of the acellular dermal matrix2*
  • Supports weak mastectomy skin flaps where weakness exists
  • Helps the surgeon to support and define inframammary and lateral mammary folds
 
*Correlation of these results to results in humans has not been established.
**Data on file
 

Mechanism of Action

Mechanism of Action
 

ALLODERM SELECT Tissue Matrix is designed to reinforce weak tissue in soft tissue reconstruction and revision surgeries. Its intricate structure offers support for the weakened breast pocket.
 
ALLODERM SELECT Tissue Matrix is human tissue that incorporates with the recipient’s own tissue, through revascularization, white cell migration, and cell repopulation,2* limiting the amount of inflammation and scar tissue formation. Inflammation and scar tissue are often associated with long-term problems in breast reconstruction and revision surgeries.
 
*Correlation of these results to results in humans has not been established.
 

FAQs

Technical FAQs

How is ALLODERM SELECT Regenerative Tissue Matrix Processed?
ALLODERM Tissue Matrix is aseptically processed from carefully screened donor tissue and rigorously tested.
 
How do I prepare ALLODERM Tissue Matrix for use in a surgical procedure?
Soak freeze dried ALLODERM Tissue Matrix for up to 40 minutes and ALLODERM Tissue Matrix Ready to Use for a minimum of two minutes in a saline bath.
 
For what surgical procedures is ALLODERM Tissue Matrix recommended?
ALLODERM Regenerative Tissue Matrix is intended to reinforce weak tissue in soft tissue reconstruction and revision surgeries.
 
How do I use ALLODERM Tissue Matrix in a surgical procedure?
Please see ALLODERM SELECT™ Tissue Matrix  Instructions for Use for more details.
 

Indications & Applications

Indications & Applications

  • Overview

Indications for Use

Before use, physicians should review complete risk information and essential prescribing information which can be found in the Instructions for Use
 
ALLODERM SELECT™ Regenerative Tissue Matrix Ready to Use (referred to herein as “ALLODERM SELECT™ RTM Ready to Use”) is donated allograft human dermis, processed to remove cells while preserving biologic components and structure of the dermal matrix. ALLODERM SELECT™ RTM Ready To Use is white to buff colored and is uniform in appearance. All labeled dimensions are at nominal values only.
 
INDICATIONS FOR USE
ALLODERM SELECT™ RTM Ready To Use is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. Each package of ALLODERM SELECT™ RTM Ready To Use is intended for use in one patient, on a single occasion.
 
ALLODERM SELECT™ RTM Ready To Use is not indicated for use as a dural substitute.
ALLODERM SELECT™ RTM Ready To Use is not intended for use in veterinary applications.
 
CONTRAINDICATIONS
ALLODERM SELECT™ RTM Ready To Use is contraindicated for use in any patient who is sensitive to any of the antibiotics listed on the package or Polysorbate 20.
 
WARNINGS
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECT™ RTM Ready To Use is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECT™ RTM Ready To Use.

DO NOT re-sterilize ALLODERM SELECT™ RTM Ready To Use.
Discard all open and unused portions of the product. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded.
DO NOT use if the pouch is opened or damaged.
DO NOT use product after expiration date noted on the label.
Transfer ALLODERM SELECT™ RTM Ready To Use from the foil pouch aseptically.
DO NOT place the foil pouch in the sterile field.

 
PRECAUTIONS
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECT™ RTM Ready To Use as such conditions may compromise successful clinical outcome.

Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECT™ RTM Ready To Use has a distinct basement membrane (upper) and dermal surface (lower). (See ORIENTATION.) When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue.

ALLODERM Regenerative Tissue Matrix has been implanted over 1.4 million times in the United States. Browse the resources below for clinical case studies and related resources.

Evidence & Outcomes

There have been more than 1 million ALLODERM™ Tissue Matrix grafts implanted to date, with ZERO documented cases of disease transmission.**

** Data on file

Clinical Evidence

Additional summary of evidence and outcomes.

Evidence & Outcomes

Evidence & Outcomes - See below

Title Study Type Date Authors