Is DuraGen considered an implant?

Is DuraGen considered an implant?

Device Description: DURAGEN 1 PK, 4×5 DOMDuraGen® Dural Graft Matrix is an absorbable implant for repair of dura matter defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfirable, porous collagen matrix.

What is DuraGen Plus?

Device Description: DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

What is DuraGen used for?

The collagen used to manufacture DuraGen Secure Dural Regeneration Matrix is currently used in the manufacture of dural repair products, artificial skin, absorbable hemostatic sponges, and absorbable wound dressings.

What is DuraGen made of?

One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application.

How do you use DuraGen?

Apply DuraGen® Secure DRY with the smooth and glossy side down. Apply gentle pressure to DuraGen® Secure for at least 10 seconds on the dural margins to ensure full surface contact. Continue holding while moistening DuraGen® Secure with saline until fully hydrated. Fluid Activated.

How is DuraGen made?

DuraGen Secure is manufactured using a collagen matrix, which is made from the same raw materials as those used to manufacture DuraGen XS5, and has an added thin layer of HPMC to one side of the collagen matrix which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such …

What is dural repair?

Dural tears are repaired using microsurgical techniques – using a microscope and a fine needle. Small dural tears are sutured or stapled close, while larger ones are reconstructed with a patch or graft. Fat or fibrin glue may be used as a sealant to reinforce the repair.

What is a dural graft?

dura. graft – material, or tissue, surgically implanted into a body. part to replace or repair a defect.

What is dura guard?

DURA-GUARD is a tough, polyurethane alkyd floor enamel designed for treating all types of interior/exterior concrete, wood and bare or primed metal surfaces. This product is specially formulated to provide a tough, mar, abrasion and mild chemical-resistant film.

How serious is a Dura tear?

Cerebrospinal fluid (CSF) leakage following dural tears can pose potentially serious problems such as CSF fistula formation, pseudomeningocele, meningitis, arachnoiditis and epidural abscess[1,3,10,12,15].

Can dural tears heal?

Dural TearA water-tight sac of tissue (dura mater) covers the spinal cord and the spinal nerves. A tear in this covering can occur during surgery. It is not uncommon to have a dural tear during any type of spine surgery. If noticed during the surgery, the tear is simply repaired and usually heals uneventfully.

Does dura heal?

Blood does not pass through the spinal cord naturally, and since blood flow is necessary to clot and heal wounds, the dural mater cannot heal on its own.