INTEGRA® Dermal Regeneration Template - P900033/S008
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: INTEGRA® Dermal Regeneration Template
Manufacturer: Integra LifeSciences Corporation
Address: 105 Morgan Lane, Plainsboro, NJ 08536
Approval Date: April 19, 2002
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p900033s008a.pdf
What is it? INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this device. I INTEGRA® may now be used to treat the often disabling scars that result from severe burns.
INTEGRA® has two layers. The bottom layer (dermal) is made of a fibrous protein material (collagen) from cows and a substance made from shark cartilage. The top layer (epidermal) is made of silicone
How does it work? When INTEGRA® is placed on a wound where the burned skin or scarred tissue has been removed, it allows blood vessels and other cells to grow a new layer of skin while the collagen is absorbed into the body. The silicone layer helps close the wound and prevent fluid loss. After approximately 14 to 21 days, the silicone layer is removed, and a very thin graft of the patient's own skin (autograft) is applied to the wound area.
When is it used? INTEGRA® is indicated for use on:
- Patients with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created
- Patients undergoing reconstructive surgery for burn scars where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created.
What will it accomplish? INTEGRA® will repair damaged skin in burn patients or patients undergoing reconstructive surgery for contractures (scars).
When should it not be used? INTEGRA® should not be used:
- On patients with known allergies to cow collagen or
- In patients with clinically diagnosed infected wounds
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p900033s008