Device Dossier

DuraMatrix Suturable - Collagen Dura Membrane - Dura mater biomatrix implant

Device Dossier for DuraMatrix Suturable - Collagen Dura Membrane - Dura mater biomatrix implant (Dura mater biomatrix implant, Class III, sponsor…

Intended purpose

DuraMatrix Suturable is indicated as a dura substitute for the repair of dura mater.

Functional description

DuraMatrix Suturable is a white, non-friable, conformable,resorbable, membrane matrix consisting of highly purified collagen derived from bovine dermis. The membrane is flexible and conforms to the contours of the defect site. The product’s mechanical strength allows the membrane matrix to be sutured in place. Animal studies show that Collagen Dura Membrane is essentially resorbed in approximately 9 months. Product is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

TGA Public Summary