FlowerDermTM Acellular Dermal Matrix
Value Analysis Resource Guide
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Table of Contents Accellular Dermis: Benefits and Clinical Applications ……………………….3 Clinical Efficacy Examples …………………………………………………………………4 FlowerDermTM………………………………………………………………………….……….5 Mechanical Testing Data..…………………………………………………………….…..6 Coding Reference Guide…………………………………..……………………………....7 Regulatory Documents………………………………………………………………………10
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Accellular Dermis Benefits
Human dermal allograft Extracellular matrix provides a scaffold for Cellular in-growth Vascularization Tissue regeneration Formation of granulation tissue Minimizes inflammation Remodels naturally without the need for chemical cross linking No residual chemicals from tissue processing Excellent moldability Composition of ECM provides proteolglycans, hyaluronic acid, collagen, fibronectin and elastin1 As well as providing a surface for cell binding, the ECM binds growth factors and cytokines, creating a reservoir of bioactive molecules that can be rapidly mobilized following injury1 to stimulate cell ingrowth and remodeling Provides structural lattice ideal for cell ingrowth1 and remodeling
Clinical Applications
1
Wound covering for non-healing wounds Abdominal wall/breast reconstruction Burn injuries Plastic and reconstructive surgery CMF soft tissue grafting Tendon reinforcement/covering
Schultz GS, Wyscocki A. Interactions between extracellular matrix and growth factors in would healing. Wound Repair Regen 2009;17(2):153-62.
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Clinical Efficacy Examples Diabetic Foot Ulcer Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomized, multicenter study. International Wound Journal. 2009 Jun; 6(3): 196-208
Achilles Tendon: A Tendon graft weave using an acellular dermal matrix for repair of the Achilles tendon and other foot and ankle tendons. J Foot Ankle Surg. 2011 Mar-Apr; 50 (2):257-65.
Abdominal Wall: Human Acellular Dermal matrix for repair of abdominal wall defects: review of clinical experience and experimental data. Journal of Long-Term effects of Medical Implants. 2005; 15(5): 547-558
Lateral Ankle: Lateral Ankle Stabilization Using Acellular Human Dermal Allograft Augmentation. J Am Podiatr Med Assoc. 2015 May; 105 (3):209-17.
Peroneal Tendons: Mid-Substance Peroneal Tendon Defects Augmented with an Acellular Dermal Matrix Allograft. Foot Ankle Int. 2010 Feb;31(2):136-40.
Nerve Wrapping: Nerve Wrapping of the Sciatic Nerve with Acellular Dermal Matrix Allograft. Foot Ankle Int. 2010 Feb;31(2):136-40.
Soft Tissue Reconstruction: Acellular Dermal Regeneration Template for Soft-tissue Reconstruction of the Digits. J Hand Surg Am. 2010 Mar;35(3):415-21.
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FlowerDerm™
Dermal Allograft – the standard for regenerative medicine Biocompatible, remodelable, acellular dermal matrix Minimizes inflammation, encourages vascularization and cell repopulation Sterile- gamma irradiated to SAL 10-6 Epidermal layer has been removed – eliminating the need to provide side specific placement Remodels naturally without the need for chemical crosslinking – avoids concerns of residual chemicals – preserves remodelability Three Thicknesses: o 0.5mm o 1.0mm o 2.2mm Provided in a variety of convenient sizes (see below) Shelf storage at ambient temperatures Read-For-Surgery – no rehydration required Part Number FDM 011
Description FlowerDerm Allograft, Thin, 1x1cm
Size (LxWxT) 10x10x0.5mm
Area (sq. cm) 1cm2
Thickness 0.5mm
FDM 012
FlowerDerm Allograft, Thin, 1x2cm
10x20x0.5mm
2cm2
0.5mm
FDM 024
FlowerDerm Allograft, Thin, 2x4cm
20x40x0.5mm
8cm2
0.5mm
20x40x0.5mm
2
0.5mm
FDM 254 FDM 454 FDM 458 FDM 101 FDM 102
FlowerDerm Allograft, Thin Meshed, 2x4cm FlowerDerm Allograft, Thin Meshed, 4x4cm FlowerDerm Allograft, Thin Meshed, 4x8cm FlowerDerm Allograft, Medium, 1x1cm FlowerDerm Allograft, Medium, 1x2cm
40x40x0.5mm 40x80x0.5mm 10x10x1mm 10x20x1mm
16cm
2
0.5mm
32cm
2
0.5mm
1cm
2
1.0mm
2cm
2
1.0mm
FlowerDerm Allograft, Medium, 1x12cm FlowerDerm Allograft, Medium, 2x4cm
20x40x1mm
8cm
FDM 404
FlowerDerm Allograft, Medium, 4x4cm
40x40x1mm
16cm2
1.0mm
40x80x1mm
32cm
2
1.0mm
25cm
2
1.0mm
50cm
2
1.0mm
FDM 505 FDM 510 FDM 264 FDM 464 FDM 468
FlowerDerm Allograft, Medium, 4x8cm FlowerDerm Allograft, Medium, 5x5cm FlowerDerm Allograft, Medium, 5x10cm FlowerDerm Allograft, Medium Meshed, 2x4cm FlowerDerm Allograft, Medium Meshed, 4x4cm FlowerDerm Allograft, Medium Meshed, 4x8cm
50x50x1mm 50x100x1mm 20x40x1mm 40x40x1mm 40x80x1mm
12cm
2
FDM 112 FDM 204 FDM 408
10x120x1mm
8cm
8cm
2
2
1.0mm 1.0mm
1.0mm
16cm
2
1.0mm
32cm
2
1.0mm
2
2.2mm
FDM 498
FlowerDerm Allograft, Thick, 4x8cm
40x80x2mm
32cm
FDM 595
FlowerDerm Allograft, Thick, 5x5cm
50x50x2mm
25cm2
2.2mm
2
2.2mm
FDM 590
FlowerDerm Allograft, Thick, 5x10 cm
50x100x2mm
50cm
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Mechanical Testing Data
Breakage Strength (Ultimate Failure Force, MPa) PRODUCT FlowerDerm Graft Jacket Max Force Craft Jacket Max Force Extreme Dermaspan Matrix DermaMatrix AlloPatch
Breakage Strength (thickness, if known) 17.2 MPa (1mm thick) 18.6 MPa (1.5mm thick) 23.2 MPa (2mm thick) 19.2 MPa (1.5mm thick) 17.2 MPa 15.7 MPa
Suture Retention Strength (Newtons, N) Product FlowerDerm Graft Jacket Max Force Craft Jacket Max Force Extreme ArthoFlex ArthoFlex
Suture Retention Strength (thickness, if known) 83 N (1mm thick) 84.7 N (1.5mm thick) 106.5 N (2mm thick) 82.6 N (1.5mm thick) 134.9 N (2mm thick)
Conclusion The standard - 1mm thick - FlowerDerm offers equivalent mechanical properties, as compared to other products, while maintaining 50% less bulk at the implant site. Innovative processing techniques allow FlowerDerm to provide adequate strength for a variety of applications, while reducing the prominence of the allograft. This makes FlowerDerm a versatile product with proven superiority.
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Procedure Coding Reference Guide HCPCS Code 4100
Description Skin substitute, not otherwise specified
CPT CODE
CPT Description
15271
Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq. cm; first 25 sq.cm or less wound surface area.
15278
Each additional 25 sq.cm wound surface area, or part thereof (list separately in addition to code for primary procedure). Application of skin substitute graft to trunk, arms, legs, total wound surface greater than or equal to 100 sq. cm; first 100 sq. cm or less wound surface area, or 1% of body area of infants and children. Each additional 100 sq.cm wound surface area, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure). Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits total wound surface area up to 100 sq. cm; first 25 sq. cm or less wound surface area. Each additional 25 sq.cm wound surface area, or part thereof (list separately in addition to code for primary procedure). Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits total wound surface greater than or equal to 100 sq. cm; first 100 sq. cm or less wound surface area or 1% of body area of infants and children. Each additional 100 sq.cm wound surface area, or part thereof (list separately in addition to code for primary procedure).
23410
Repair of Ruptured musculotendinous cuff (eg, rotator cuff) open; acute
23412
Repair of Ruptured musculotendinous cuff (eg, rotator cuff) open; chronic
23420
Reconstruction of complete shoulder (rotator) cuff avulsion, chronic (includes acromioplasty)
23470
Arthroplasty, glenohumeral joint; hemiarthroplasty
15272 15273 15274 15275 15276 15277
23472
Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder))
23473
Revision of total shoulder arthroplasty, including allograft when performed; humeral or glenoid component
23474
Revision of total shoulder arthroplasty, including allograft when performed; humeral and glenoid component
23800
Arthrodesis, glenohumeral joint 7|Page
23929
Unlisted procedure, shoulder
26476
Lengthening of tendon, extensor, hand or finger, each tendon
26478
Lengthening of tendon, flexor, hand or finger, each tendon
26502
Reconstruction of tendon pulley, each tendon; with tendon or fascial graft (includes obtaining graft) (separate procedure)
26545
Reconstruction, collateral ligament, interphalangeal joint, single, including graft, each joint
27422
Capsulectomy or capsulotomy, hip, with or without excision of heterotopic bone, with release of hip flexor muscles (ie, gluteus medius, gluteus minimus, tensor fascia latae, rectus femoris, sartorius, iliopsoas) Reconstruction of dislocating patella; with extensor realignment and/or muscle advancement or release (eg, Campbell, Goldwaite type procedure)
27428
Ligamentous reconstruction (augmentation), knee; intra-articular (open)
27430
Quadricepsplasty (eg, Bennett or Thompson type)
27599
Unlisted procedure, femur or knee
27652
Repair, primary, open or percutaneous, ruptured Achilles tendon; with graft (includes obtaining graft)
27654
Repair, primary, open or percutaneous, ruptured Achilles tendon; with graft (includes obtaining graft)
27659
Repair, flexor tendon, leg; secondary, with or without graft, each tendon
27665
Repair, extensor tendon, leg; secondary, with or without graft, each tendon
27685
Lengthening or shortening of tendon, leg or ankle; single tendon (separate procedure)
27686
Lengthening or shortening of tendon, leg or ankle; multiple tendons (through same incision), each
27899
Unlisted procedure, leg or ankle
28200
Repair, tendon, flexor, foot; primary or secondary, without free graft, each tendon
28208
Repair, tendon, extensor, foot; primary or secondary, each tendon
28735
Arthrodesis, midtarsal or tarsometatarsal, multiple or transverse; with osteotomy (eg, flatfoot correction)
28899
Unlisted procedure, foot or toes
29826
Arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with coracoacromial ligament (ie, arch) release, when performed (List separately in addition to code for primary procedure)
29827
Arthroscopy, shoulder, surgical; with rotator cuff repair
27036
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The information provided in this document is for reference only based on third party publications and is subject to change without notice, including as a result in changes in reimbursement laws, regulations, rules, and policies. All content in this document is informational only, general in nature, and does not cover all situations, or all payers rules and/or policies. Not all codes may be used together, and certain codes may not be applicable for a given procedure or treatment. The service and the product must be reasonable and necessary for the care of the patient to support reimbursement. Flower Orthopedics does not, and cannot suggest the appropriate code for a given clinical situation or patient. This document represents no guarantee or promise by Flower Orthopedics for coverage by Medicare, Medicaid, or any other insurance program, of a given patient visit, procedure, or treatment; providers are solely responsible to confirm eligibility and appropriateness with respect to coding and billing. Flower Orthopedics specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information in this guide.
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Regulatory Documents
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