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ELEVATING THE STANDARD OF CARE
MIMEDX PLACENTAL-BASED ALLOGRAFTS
SOLUTIONS FOR CHALLENGING CLOSURES
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RISK FACTORS:
IMPAIRED HEALING AND/OR DELAYED CLOSURE1-9
Patient• Diabetes
• Older age
• Obesity
• Smoking
• Vascular disease
• Immune suppression
• Immune disease
• Immobilization
Defect / Wound• Contamination or infection
• Exposed tendon or bone
• Recurrence
• Irradiated tissue
• Size or depth of defect (e.g. tunneling wound)
Timing• Slow healing
• Chronic wound
• Not yet candidate for definitive closure
• Cancer
• Poor nutrition
• Neuropathy
• Systemic medications
• Chronic inflammation
• Demographic factors
• Psychosocial factors
• Non-compliance
More Comorbidities = Higher Risk of Complications2**In certain patient populations
!
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Support Tissue Closure and Reduce Postop Complications
MIMEDX PLACENTAL-BASED ALLOGRAFTS:
SOLUTIONS FOR CHALLENGING CLOSURES
After debridement, MiMedx allografts are often used in conjunction with Negative Pressure Wound Therapy (NPWT).
CLOSURE OPTIONS CLINICAL GOALS
FLAPS• Improve flap viability• Decrease number and/or size of flaps• Downgrade flap to skin graft
SKIN GRAFTS• Improve skin graft viability• Bridge to skin graft• Downgrade to secondary intention
PRIMARY CLOSURE
• Provide protective environment to support the healing cascade
• Reduce potential for dehiscence & complications
SECONDARY INTENTION
• Provide protective environment to support the healing cascade
• Reduce potential for complications• Decrease time to closure
Acute and Chronic ClosuresAcute and chronic closures may need an advanced intervention to help rebalance the wound bed, facilitating normalization of the healing cascade.
Clinically and Cost EffectiveMiMedx advanced placental-based allografts have demonstrated in randomized controlled trials (RCTs) to be clinically and cost effective, and are appropriate for comorbid patients with challenging closures.10-20
RECONSTRUCTIVE LADDER
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EpiXL + NPWT in comorbid patient with 3-year-old chronic VLU that failed multiple treatments (e.g. HBO, skin substitutes, biologics, and two skin graft attempts with NPWT).21
EpiFix in a neuropathic diabetic patient with scheduled amputation avoided.22
84-year-old male with multiple comorbidities and exposed Achilles tendon. Patient had 20 years of steroid use and prior closure attempts including biologic treatments which had failed one year prior to presentation. One week after initial debridement, no granulation tissue was present, so EpiFix was applied.23
Week 1: s/p debridement EpiXL + NPWT
Week 2 Week 3 Day 35: Wound stable at 3, 6, and 12 Month follow-ups
Initial examination Week 6: s/p one EpiFix application. Healthy granulation prep for STSG
Week 16: STSG mostly closed except small area above grafted area
Week 22: Wound closed and stable
Comorbidities:DM, CVI, and HTNGoal: Secondary Intention Wound Closure
Comorbidities: PVD and pyodermaRisk Factors: 20 years of steroid use and one year history of failed prior closure attemptsGoal: Bridge to STSG
Comorbidities: DM and neuropathyGoal: Secondary Intention Wound Closure
CHALLENGING PATIENT CLOSURE: CASE EXAMPLES
Diabetic Foot Ulcer (DFU): EpiFix® + NPWT
Exposed Achilles Tendon: EpiFix
Venous Leg Ulcer (VLU): EpiXL® + NPWT
AKA = Above the Knee Amputation; BKA = Below the Knee Amputation; COPD = Chronic Obstructive Pulmonary Disease; DFU = Diabetic Foot Ulcer; DM = Diabetes Mellitus; DVT = Deep Vein Thrombosis; HTN = Hypertension; LLE = Left Lower Extremity; PE = Pulmonary Embolism; PVD = Peripheral Vascular Disease; RLE = Right Lower Extremity; s/p = status post; STSG = Split-Thickness Skin Graft
Patient presented with osteomyelitis and underlying purulent tissue
Post-Debridement + NPWT initiated
Week 8: First EpiFix application after insurance coverage was received
Week 15: Wound closed, s/p 4 total EpiFix applications
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Comorbid elderly patient with BKA due to non-healing wounds and osteomyelitis had surgical site dehiscence twice and remained open for six months. BKA was converted to AKA, patient continued smoking, and the surgical site dehisced. Patient underwent two more surgical debridements with secondary wound closures. AmnioFix was applied during the third surgical debridement and wound closed.24
Bridge to STSG and limb salvage with AmnioFill and NPWT in elderly, comorbid patient.25
Unilateral flap reconstruction for sacral defect in an elderly patient who upon initial presentation was not an operative candidate.26
BKA post-operative wound dehiscence on surgical day of debridement and repeat primary closure
Wound dehiscence less than six months after surgical debridement and primary closure
Extensive debridement of recurrent dehiscence of AKA prior to placement of AmnioFix
Week 4: Complete wound closure s/p debridement and one AmnioFix application
Limb Salvage: AmnioFill® + NPWT
Flap: AmnioFix, AmnioFill + NPWT
BKA to AKA after Recurrent Dehiscence: AmnioFix®
312 cm2 sacral wound s/p 3rd debridement
Week 6: s/p 3 combination treatments: AmnioFix Injectable and sheet + NPWT (1x) and AmnioFill, AmnioFix sheet + NPWT (2x)
Week 8: Unilateral fasciocutaneous flap, AmnioFill and AmnioFix sheet treatment
Week 14: No wound closure complications s/p 6 Weeks
Note: Individual results may vary.
Comorbidities: Morbid obesity, HTN, history of DVT, PE, aortic dissection, and smokingGoal: Bridge to STSG
Comorbidities: COPD, obesity, PVD, peripheral neuropathy, HTN, and smoking (two packs per day)Goal: Secondary Intention Wound Closure
Comorbidities: DM and morbid obesityGoal: Decrease size of defect and improve flap viability
CHALLENGING PATIENT CLOSURE: CASE EXAMPLES
RLE wound at consultation Week 2: s/p 2 debridements and 2 AmnioFill treatments + NPWT
Week 6: Ready for STSG 6.5 weeks post initial debridement, 2 AmnioFill treatments + NPWT
STSG placed week 8. Image Week 13, 5 weeks post STSG
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ADVANCED TREATMENTS:
FOR THE OFFICE, CLINIC, AND OPERATING ROOM
Dehydrated umbilical cord allograft with ECM and 250+ regulatory proteins.29,30
• Smaller, deeper wounds or surgical sites
• When graft fixation is desired• Provides a barrier membrane• 2 cm x 3 cm expands to 12 cm2
(EpiCord Expandable)31
Placental-based tissue matrix with ECM and 300+ regulatory proteins27-29 in a particulate configuration.
• OR/Surgical setting• Larger & uneven wound surface areas• Deep or tunneling wounds
OPERATING ROOM
OFFICE OR CLINIC
Follow-up with EpiFix or EpiCord in Office or Clinic
EXPANDS
Dehydrated human amnion/chorion membrane allograft with extracellular matrix (ECM) and retains 300+ regulatory proteins27-29 in sheet and micronized configurations.
• Acute and chronic wounds• Provides a barrier membrane (sheet)
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PIONEERING SCIENCE:
COMMITMENT TO INNOVATION
SMR2T TECHNOLOGY: POWER(Selective Membrane of Reparative and Reconstructive Tissue)
• Protects the wound bed to aid in the development of granulation tissue
• Provides a human biocompatible extracellular matrix
• Retains 250+ regulatory proteins27-30
PURION PATENTED PROCESSING: SAFETY FIRST
• Donated from C-sections of live births in the US
• Active preservation of extracellular matrix (ECM), regulatory proteins, and removal of blood contaminants via a proprietary cleansing process
• Terminally sterilized for additional level of safety
A semi-permeable protective barrier that supports the healing cascade
A unique, patented process for placental-based allografts
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REFERENCES1. Atkin, et al. J Wound Care 2019;28(3 Suppl 3):S1-S49 2. Thombs, et al. Ann Surg. 2007 Apr;245(4):629-34 3. Guo and Dipietro. J Dent Res. 2010 Mar;89(3):219-29 4. Martin, et al. Infect Control Hosp Epidemiol. 2016;37(1):88-99 5. Myles, et al. Anesthesiology. 2002 Oct;97(4):842-7 6. Everhart, et al. Clin Orthop Relat Res. 2013 Oct;471(10):3112-9 7. Ventral Hernia Working Group, Breuing, et al. Surgery. 2010 Sep;148(3):544-58 8. Finan, et al. Am J Surg. 2005 Nov;190(5):676-81 9. Armstrong, et al. N Engl J Med 2017 376(24):2367-75 10. Zelen, et al. Int Wound J. 2013 Oct;10(5):502-7 11. Zelen, et al. J Wound Care. 2013 Jul;22(7):347-8, 350-1 12. Zelen, et al. Wound Medicine. 2014 Feb;4:1-4 13. Zelen, et al. Int Wound J. 2014 Apr;11(2):122-8 14. Zelen, et al. Int Wound J. 2015 Dec;12(6):724-32 15. Zelen, et al. Int Wound J. 2016 Apr;13(2):272-82 16. Tettelbach, et al. Int Wound J. 2018;1-11 17. Tettelbach, et al. Int Wound J. 2019;16:122–130 18. Serena, et al. Wound Repair Regen. 2014 Nov-Dec:22(6)688-93 19. Bianchi, et al. Int Wound J 2018 Feb;15(1):114-22 20. Bianchi, et al. Int Wound J. 2019 Jun;16(3)761-67 21. Jackson. VLU Case Example, Data on File at MiMedx 22. Tettelbach. DFU Case Example, Data on Field at MiMedx 23. Davenport. Exposed Achilles Tendon Case Example, Data on File at MiMedx 24. SB933, Lower Extremity Amputation with AmnioFix 25. SB933, Lower Extremity Amputation with AmnioFix 26. SB934, Unilateral Flap with AmnioFill, AmnioFix, and NPWT 27. Koob, et al. J Biomed Mater Res B Appl Biomater. 2014 Aug;102(6):1353-62 28. Lei, et al. Adv Wound Care. 2017 Feb 1;6(2):43-53 29. MM-RD-00086, Proteome Characterization of Purion Processed Dehydrated Human Amnion Chorion Membrane (dHACM) and Purion Plus Processed Dehydrated Human Umbilical Cord (dHUC) Allografts 30. Bullard, et al. J Biomed Mater Res B Appl Biomater. 2019 May;107(4):1035-1046 31. See MiMedx Product Instructions for Use for further details 32. SmartTrak, Accessed Sept 2020
Patents and patents pending see: www.mimedx.com/patents. AmnioCord, AmnioFill, AmnioFix, EpiCord, EpiFix, Purion, SMR2T, and MiMedx are trademarks of MiMedx Group, Inc. ©2020 MiMedx Group, Inc. All Rights Reserved. www.mimedx.com OUS110.001
Customer Service: +1 866.477.4219Email: customerservice@mimedx.comPatient Insurance Verification Team: +1 855.882.8480
To find out more about MiMedx products or to start an evaluation:
PRODUCT ADVANTAGES:• Terminally sterilized for
additional level of safety
• Easy to apply
• Room temperature storage
• 5-year shelf life
BACKED BY:• 300M+ lives covered by insurance for
MiMedx products
• Reimbursement team that provides information and education on coverage and insurance verification for MiMedx products
2.5Complete
Wound Closure
#1 Amniotic Skin Substitute32
7 RCTs: Demonstrated Clinical Data10-20
40+ Clinical and Scientific Publications
Average Number of Treatments to Closure13
Observed 90+% Complete Wound Closure in DFUs at 6 Weeks 10,14,15
MARKET LEADER:
PLACENTAL-BASED ALLOGRAFTS
DISCLAIMER:The claims made in relation to the products identified in this piece are subject to MiMedx’s interpretation of applicable United States Food and Drug Administration guidelines and regulations. Additionally, some of the displayed products are available in territories outside of the United States, and, to the extent they are available, they are sold and distributed subject to approval by local regulatory authorities. Please contact a MiMedx representative to confirm the availability of identified products in your country of interest. The content provided herein is intended for informational purposes only.
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