Search Results

The BioBridge™ Collagen Matrix is intended to reinforce soft tissue where weakness and deficiencies exist, specifically, for reinforcement of soft tissue repaired by suture anchors in tendon repair, including small tendons, ligaments, and general surgical procedures for tissue repair where weakness exists, including muscle flap reinforcement. BioBridge is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair.

BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen that is designed to provide mechanical support for weaknesses and deficiencies in soft tissue. The collapsed ribbon structure contains multiple folds of a thin membrane with aligned collagen fibrils in the same lengthwise direction. This structure provides mechanical properties that contribute to strong tensile strength, that which provides support to weaknesses and deficiencies in soft tissue and aids in bridging a connection between two healthy soft tissues. BioBridge is fabricated using a proprietary manufacturing process that produces a narrow and very thin ribbon-like membrane comprised of collagen fibrils, creating a multiluminal structure that provides mechanical properties for support of soft tissue repair. This approach presents the opportunity to enable the use of highly purified, pepsin treated collagen, in a defined structure that has mechanical properties similar to those of the predicates. The smaller ribbon-like form factor gives the surgeon greater flexibility to tailor their procedures compared to the predicates without changing the intended use. One or more BioBridge devices can be implanted depending on the surgeon's discretion, including arrangement of the individual devices in bundles or braided together by the physician, to better address a specific patient need. It is particularly well suited, for example, in supporting repair of small tendons and ligaments. Fibralign sources the highly purified porcine-derived Type I collagen from an FDA-registered and ISOqualified supplier. Fibralign employs a proprietary manufacturing process that takes highly purified porcine-derived Type I collagen and produces narrow, ribbon-like membranes comprised of highly aligned collagen fibrils that provides mechanical strength for use in supporting soft tissue. A chemical crosslinking agent is used during the manufacturing process to promote the crosslinking of the collagen but the crosslinker itself is not added to nor bound to the collagen matrix. The crosslinker residuals are water soluble and are removed by product rinsing at the end of the production process. The final product is packaged into individual storage containers and then sealed within an outer tray and terminally sterilized.