FlowerDermTM Acellular Dermal Matrix

Value Analysis Resource Guide

1|Page

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

2|Page

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.

3|Page

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.

4|Page

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

5|Page

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.

6|Page

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

8|Page

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.

9|Page

Regulatory Documents

10 | P a g e

11 | P a g e

12 | P a g e

13 | P a g e

14 | P a g e