Architect® is an advanced collagen wound matrix for the management of complex skin wounds. EPMatrix® is a collagen scaffold for soft tissue repair and reinforcement. Both products start with a highly organized, Type I collagen, sourced from a high quality Xenograft. Unlike reconstituted collagen products, the native architecture and collagen structure, orientation, and strength are preserved.
Clinical experience and Mechanism of Action data suggest products such as Architect® and EPMatrix® stabilized collagen matrices support tissue regeneration by providing a healthy wound healing environment.
What Makes the BriDGE Stabilization Technology Unique?
Stabilization methods can affect tissue performance, including bio-mechanics and bio-compatibility. BriDGE® technology utilizes a unique and patented, flexible stabilization technology with distinct advantages over conventional crosslinking methods.
- BriDGE® stabilization maintains the native collagen architecture and mechanical properties to support healing.
- BriDGE® stabilization reinforces the collagen matrix to resist premature degradation.
- BriDGE® stabilization allows for varying degrees of stabilization (or partial stabilization) for use in specialized products.
- BriDGE® processed products are non-toxic and bio-compatible, and free of harsh chemicals such as glutaraldehyde and diisocyanates.
UNCOMPROMISING PERFORMANCE & BIOCOMPATIBILITY
- Architect® and EPMatrix® start with a superior tissue substrate (tri-layered, type I collagen).
- Architect® is shipped dry and sterile, ready for use in a matter of minutes.
- Architect® lays flat and has excellent tensile, suture and staple properties.
- Architect® utilizes patented BriDGE® technology which stabilizes and protects against collagen degeneration, allowing for uninterrupted healing support.
- Architect® and EPMatrix® are non-toxic, non-mutagenic, and non-irritant.
STEP ONE: DECELLULARIZATION
Decellularization is the process used to create an acellular (without cells) extracellular matrix (“ECM”). The BriDGE® decellularization process gently removes intra-cellular debris while preserving ECM fibers, growth factors, and other proteins of the natural tissue. The result is a clean, uniform scaffold, with <5% residual cellular material remaining, allowing for improved bio-compatibility.
STEP TWO: STABILIZATION
Why should collagen scaffolds and advanced “skin substitutes” be stabilized? ECMs contain important tissue regeneration properties. But those tissue regeneration properties are only available if the ECM is not degraded or compromised. For instance, chronic wounds are characterized by excessive enzymes including matrix metalloproteases (MMPs) and other proteases that prevent the wound from progressing from the inflammatory phase to the proliferation phase. These same enzymes act to rapidly degrade ECMs that are not stabilized, causing frequent and costly re-application. With BriDGE®, the ECM is stabilized to prevent rapid degradation, and maintaining a healthy ECM helps to continually support tissue regeneration.
Type I Collagen Molecular Structure
Collagen is the major insoluble fibrous protein in the ECM and in connective tissue. Type I collagen was selected (in part) because of its highly organized structure and superior tensile strength.
Protease impact on Un-Stabilized Collagen
Enzymatic protease are attracted to the amino chains within collagen molecules. Left un-stabilized, these protease attack and break down the amine groups which hold collagen molecules together.
STEP THREE: PRESERVATION
Architect® and EPMatrix® are preserved using lyophilization (freeze drying). Although expensive and complicated, this step provides added convenience, including:
- Easy Transport – Architect® and EPMatrix® are lightweight and require no bulky packaging, or special shipping.
- Easy Storage – Architect® and EPMatrix® may be stored Ambient (no special refrigeration or equipment needed).
- Long Shelf Life – Architect® and EPMatrix® support a long shelf life.
- Easy Rehydration – Architect® and EPMatrix® take only moments to rehydrate prior to use.
STEP FOUR: TERMINAL STERILIZATION
Architect® and EPMatrix® are Terminally Sterilized using Electron Beam (e-Beam) Sterilization.
Like most devices, BriDGE® products are also “processed under controlled conditions” or “Aseptically processed”.
Unlike most other similar products, Architect® and EPMatrix® take additional steps to Terminally Sterilize in a double peel pouch for additional safety and convenience.
Architect® and EPMatrix® are validated as STERILE, meeting a Sterility Assurance Level (SAL) of <10^-6.