Matrix HD. wound covering. Sterile, room temperature human dermis graft

Transcription

1 Matrix HD wound covering Sterile, room temperature human dermis graft

2 Matrix HD wound covering Sterile, room temperature human dermis graft Matrix HD is an acellular human dermis allograft sterilized using the Tutoplast Tissue Sterilization Process. This proprietary process retains the three dimensional intertwined multidirectional fibers and mechanical properties of the native tissue architecture. The Matrix HD graft provides a natural collagen scaffold to support the body s regenerative processes. Wound Care Cases Diabetic Foot Ulcer Patient presented with a diabetic ulcer with exposed tendon and bone on the dorsal aspect of the foot. The surgeon used multiple Matrix HD grafts to cover the entire surface of the wound. At three weeks the wound showed a decrease in wound depth and significant granulation tissue present. Initial presentation graft application Matrix HD at a Glance Sterile Terminally sterilized SAL 10-6 Validated viral inactivation Biocompatible Preserved vascular channels Preserved key components of collagen matrix Revascularization evident in as early as 7 days in an animal model* Well suited for use during treatment of chronic wounds Convenient Room temperature storage** 5 year shelf life Simple single step rehydration *Greenspan DC, Hernandez R, Faleris J. Histology of Surgically Implanted Tutoplast Processed Dermis. Unpublished data, **See graft labeling for storage temperature range. Insect Bite 3 weeks Patient presented with an infected insect bite with exposed tendon and bone on the dorsal aspect of the foot. The wound required two Matrix HD graft applications. At 10 weeks the wound showed 70% decrease in size and 80% granulation tissue coverage. Initial debridement graft application 10 Weeks

3 Convenient The Tutoplast Tissue Sterilization Process utilizes solvent dehydration to allow for room temperature storage with a 5 year shelf life. This proprietary processing step eliminates the need for freezing or refrigeration of the graft. The unique storage characteristics of Matrix HD create convenient, on-the-shelf storage for easy access and use. The preparation of Matrix HD requires minimal effort and time. The graft requires a single rehydration step in room temperature sterile saline. The quick rehydration of the Matrix HD graft can reduce OR time and costs. Biocompatible The donated human tissue source of Matrix HD produces a biocompatible intact porous scaffold for cellular proliferation and revascularization. The Tutoplast process preserves the key components of collagen matrix that allow for a natural healing response. In-Vivo Animal Model Study Matrix HD functions successfully as a scaffold and is fully incorporated and remolded by the host tissue. Day 1 Beginning of cellular infiltration of the graft by host tissue. Day 7 Vascularization evident, invasion of fibrolasts and other cells found in normal healing cascade of the graft by host tissue. WEEK 8 Difficult to distinguish implant from host tissue graft is well incorporated. WEEK 16 Nearly complete incorporation and remodeling of the graft had occurred. Greenspan DC, Hernandez R, Faleris J. Histology of Surgically Implanted Tutoplast Processed Dermis. Unpublished data, 2008.

4 The Tutoplast Tissue Sterilization Process is a validated chemical sterilization methodology specifically developed to sterilize and preserve membrane and soft tissue augmentation grafts for implantation. Sterile Tutoplast Tissue Sterilization Process The Tutoplast process is comprised of a series of soaks to remove lipids, proteins, and bacterial spores, with a final wash to inactivate enveloped viruses. Solvent dehydration results in room temperature storage of tissue without damaging the collagen structure. Low dose gamma irradiation ensures sterility of final packaged graft. Thoroughly penetrates tissue Osmotic treatments disrupt cell membranes to allow for full penetration of graft Validated Viral Inactivation Ability to inactivate or remove HIV, hepatitis, fungi, and spores Validated by individual tissue type based on worst case testing using most difficult to kill organisms Terminally Sterilized Validated low dose gamma irradiation Achieves terminal sterility of SAL 10-6

5 Natural Dermal Matrix In-Process Dermal Matrix Implantable Acellular Delipidization Removes lipids and red and white blood cells. Osmotic Treatment Disrupts cell membranes to allow easier removal of cellular components. Oxidative Treatment Removes immunogenic structures, enveloped and non-enveloped viruses. Solvent dehydration Preserves the natural tissue matrix and allows for five-year shelf life. Irradiation Low-dose irradiation produces a terminally sterile graft, while preserving structural integrity. Pre-processed vs. Tutoplast Processed Human Dermis Pre-processed Human Dermis Note presence of intact epidermis. Tutoplast Processed Human Dermis Note epidermis has been removed and underlying matrix has been preserved. Pre-processed Human Dermis Note the presence of cellular debris throughout (purple cell nuclei). Tutoplast Processed Human Dermis Note the absence of cellular debris and the intact tissue matrix.

6 Reimbursement HCPCS CODE FOR MATRIX HD GRAFTS Effective January 1, 2013, the Centers for Medicare & Medicaid Services (CMS) assigned a new brandspecific Level II HCPCS code, Q4128, to Matrix HD. CMS has indicated that these brand-specific HCPCS codes are applicable for all sites of service that use the Matrix HD implant. Code Q4128 Description Flex HD, Allopatch HD, or Matrix HD, per square cm Use of the HCPCS Q-code does not guarantee payment. You should select the most appropriate codes for the procedures performed. Coding practices will vary by the site of care, patient condition, range of services provided, local carrier instructions, and other factors. The decision about how to complete a reimbursement claim form, including billing amounts, is exclusively the responsibility of the provider. Coding regulations are subject to change at any time. Ordering Information Code Description TD2203 Matrix HD 2cm x 3cm TD0214 Matrix HD 2cm x 14cm TD0405 Matrix HD 4cm x 5cm TD0508 Matrix HD 5cm x 8cm TD1010 Matrix HD 10cm x 10cm TD1315 Matrix HD 13cm x 15cm TDF405 Matrix HD Fenestrated 4cm x 5cm TDF508 Matrix HD Fenestrated 5cm x 8cm To order, call RTI directly: Research Circle Alachua, Florida Toll Free: Fax: Reimbursement Info: Call Tutoplast is a U.S. registered trademark of Tutogen Medical GmbH. Matrix is a trademark of RTI Biologics, Inc RTI Biologics, Inc R2 05/28/13