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Literature Silverlon Antimicrobial Wound Dressing L1 Enterprises is an Authorized Reseller of Silverlon Wound Dressings Available Direct Via FSS #36F79719D0097 (link: Federal Supply Schedule (FSS) Contract #36F79719D0097) Government Purchase Card For Information Contact L1 Enterprises Email: [email protected]; Telephone: 301.698.5798 Website: www.L1Enterprises.com MEDICAL EQUIPMENT, SUPPLIES, & SERVICES &

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Page 1: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

LiteratureSilverlon Antimicrobial Wound Dressing

L1 Enterprises is an Authorized Reseller of Silverlon Wound Dressings

Available Direct Via FSS #36F79719D0097

(link: Federal Supply Schedule (FSS) Contract #36F79719D0097)

Government Purchase Card

For Information Contact L1 Enterprises Email: [email protected]; Telephone: 301.698.5798

Website: www.L1Enterprises.com

MEDICAL EQUIPMENT, SUPPLIES, & SERVICES

&

Page 2: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated 618 W. Patrick St., Frederick, MD 21701

Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Table of Contents

Exhibit A -Clinical Studies Bibliography Exhibit B -Silverlon Life Saver Discs Exhibit C-Silverlon Performance Surgical Dressing Exhibit D -Advanced Wound Care & Burn Dressing Exhibit E -Silverlon Flex Tape Dressing

Page 3: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated

618 W. Patrick St., Frederick, MD 21701 Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Exhibit A -Clinical Studies Bibliography

Page 4: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

BIBLIOGRAPHY

Independent, peer-reviewed, and published clinical studies suggestSilverlon® Dressings can be an important element in wound care, and control of wound bacteria within the dressing may help reduce the risk of infection.Please note that these studies may involve findings that exceed the claims currently cleared by the FDA for the product. Argentum Medical, LLC is not intending to make performance claims about its product. The intent is to disseminate the scientific literature on these products. We encourage you to read these studies to understand the strengths and limitations of the data. For some claims, Argentum is seeking to broaden the indications with the FDA in the future using data, such as these studies, to provide the substantiation.

Studies are available for download at Silverlon.com/clinical-studies

Burns and Military

• The Use of a Silver–Nylon Dressing During Evacuation of Military Burn Casualties Authors: Amit Aurora, D.Eng1, Alexander Beasy, BA1, Julie A. Rizzo, MD1,2, and Kevin K. Chung, MD2,3

• 1 U.S. Army Institute of Surgical Research, JBSA, Fort Sam Houston, TX, USA 2 Uniformed Services University of the Health Sciences, Bethesda, MD, USA 3 Brooke Army Medical Center, JBSA, Fort Sam Houston, TX, USA• Publication: Journal of Burn Care & Research

• Military Applications of Silver-Nylon Dressings Author: David J Barillo MD FACS FCCM

• Winchester Medical Center, Winchester VA, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries, 2014

• Silverlon® use in Afghanistan for Burn Care Authors: Mary-Margaret Brandt MD, Margaret Tait MT (ASCP), Thomas Toddanio MA MT (ASCP), Wendy Wahl MD

• University of Michigan Burn Center, MI, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries, 2014

• Comparison of Silverlon® Dressing to Xeroform™ Gauze in the Treatment of Skin Graft Donor Site WoundsAuthors: Michale C. Albrecht MD, Evan Renz MD, Leopoldo C. Cancio MD, Christopher E. White MD, Lorne H. Blackbourne MD,Kevin Chung MD, Eric E. Horvath DO, Peggy Bielke RN, David Baer PhD, Steven E. Wolf MD, John B Holcomb MD• U.S. Army Institute of Surgical Research, Fort Sam Houston, TX, USA

• A Literature Review of the Military Uses of Silver-Nylon Dressings with Emphasis on Wartime OperationsAuthor: David J Barillo, MD, FACS, FCCM• Mount Pleasant, SC, USA Italian Army Medical Service & Universita` degli Studi di Modena e Reggio Emilia, Emilia-Romagna, ITALY Department of Surgery, St. Joseph Mercy Hospital-Ann Arbor, Ann Arbor, MI, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries, 2014

Wounds

• A Clinical Evaluation of Silverlon® Wound Contact Layer Antimicrobial Wound Dressing Author: Gareth Owen• ManchesterRoyalInfirmary,UK

• Chronic, Diabetic Foot Wounds with Ischemia and Tissue Loss: Use of Advanced Wound Care Techniques, Silver Plated Cloth, Allografts and Vascular Intervention to Prevent Further Tissue Loss

Authors: Dr. Stanley N. Carson MD FACS, Eric Travis DPM, Diana To MPT

• Treatment of Pyoderma Gangrenosum with a Silver Contact LayerAuthor: Dr. Carl Van Gils• Dixie Regional Medical Center Wound Clinic, St. George, UT, USA

• Utilizing Silver-Plated Fabric with Negative Pressure Wound Therapy: Improving Outcomes and Reducing Costs in Healing Acute and Chronic WoundsAuthor: Tina Baum, MS, CNS, ACNS-BC, CWON• Florida Hospital, North Pinellas, FL, USA

LC-SMM-55, REV. A

Page 5: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silver In Medicine

• Silver in Medicine: A Brief History BC 335 to Present Authors: David J Barillo MD FACS FCCM, David E. Marx DVM

• Mount Pleasant, SC, USA• University of Scranton, Scranton, PA, USA

• Silver In Medicine: The Basic Science Authors: David J Barillo, MD FACS FCCM, David E. Marx DVM

• Mount Pleasant, SC, USA University of Scranton, Scranton, PA, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries, 2014

• Silver-Resistance, Allergy, and Blue Skin: Truth or Urban Legend? Author: Dr. Jose P. Sterling, MD

• St. Vincent Regional Medical Center, Santa Fe, NM, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries, 2014

Negative Pressure Wound Therapy

• Silver Negative Pressure Dressing With Vacuum-assisted Closure of Massive Pelvic and Extremity Wounds Authors: Herrick J. Siegel MD, Diego F. Herrera MD, Jason Gay CRNFA

• University of Alabama at Birmingham (UAB), Birmingham, AL, USA• Publication: Clinical Orthopaedics and Related Research

• WoundHealingandCost-SavingBenefitsofCombiningNegative-PressureWoundTherapywithSilver Authors:JeffreyC.KarrDPM,FernandoLoretdeMolaMD,TriPhamMD,LeslieTookeRN

• The Wound Care Center at Lakeland Regional Medical Center, Lakeland, FL, USA• Publication: Advances in Skin & Wound Care

Central Line Catheter

• Reduction in Central Line–Associated Bloodstream Infections Correlated With the Introduction of a Novel Silver-Plated Dressing for Central Venous Catheters and Maintained for 6 Years

Authors: Rachel Karlnoski PhD1, Elia Charbel Abboud MD1, Peggy Thompson BSN CIC FAPIC2, Asa Z. Oxner MD3, John T. Sinnott, MD FACP4, Jorge E. Marcet MD FACS FASCRS1

• 1 Department of Surgery, University of South Florida, Morsani College of Medicine, Tampa, FL, USA 2 Department of Infection Prevention, Tampa General Hospital, Tampa, FL, USA 3 Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA 4 Department of Internal Medicine, University of South Florida, Morsani College of Medicine, Tampa, FL, USA• Publication: Journal of Intensive Care Medicine 1-6

• Non-Inferiority of a Novel Silver-Plated Dressing for Central Venous Catheters: A Retrospective Cohort Evaluating Rates of Central Line-Associated Bloodstream Infections in Adult Intensive Care Patients

Authors: Asa Oxner MD, Andrew Myers MD, John Sinnott MD, Jorge Marcet MD, Jillian Sajdak, Peggy Thompson BSN CIC, Charles Myers• U. of South Florida College of Medicine, Tampa General Hospital, Tampa, FL, USA• Presented at: Infectious Disease Society of America Annual Conference, 2011

Surgical

• Use of a Silver Nylon Dressing Following Total Hip and Knee Arthroplasty Decreases the Postoperative Infection Rate Authors: Ashley J. Tisosky MD1, Otatade Iyoha-Bello BSc2, Nicholas Demosthenes BA3, Giovanni Quimbayo MD2, Tara Coreanu

BSc4, Ayesha Abdeen MD FRCSC5

• 1 Department of Orthopaedic Surgery, Harvard Combined Orthopaedic Residency Program, Massachusetts General Hospital, Boston, MA, USA

2 Department of Orthopaedic Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA 3 Department of Health Care Quality, Beth Israel Deaconess Medical Center, Boston, MA, USA 4 Faculty of Health Sciences, Clinical Research Center, Soroka Universtity Medical Center, Ben-Gurion University of the

Negev, Beer-Sheba, ISRAEL 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA• Publication: JAAOS - Journal of the American Academy of Orthopaedic Surgeons

• The Use of Silver Nylon in Preventing Surgical Site Infections Following Colon and Rectal Surgery Authors: Beth Krieger MD, Donald M. Davis MD, Jaime E. Sanchez MD, James J. Mateka, Valentine N. Nfonsam MD, Jared C. Frattini MD, Jorge E. Marcet MD

• Department of Surgery, Division of Colon and Rectal Surgery, University of South Florida, Tampa, FL, USA• Publication: Diseases Of The Colon & Rectum

• AClinicalTrialtoInvestigatetheEffectofSilverDressingsonMediastinitisRatesinPostoperativeCardiac Sternotomy Incisions

Authors: Roger Huckfeldt MD FACS, Clyde Redmond MD, Debbie Mikkelson BSM, Phillip J. Finley MS, Cindy Lowe BS CCRP, Jennifer Robertson RN

• StJohn’sRegionalHealthCenter,Springfield,MO,USA• Publication: Ostomy Wound Management

• Do Silver-Impregnated Dressings Limit Infections After Lumbar Laminectomy with Instrumented Fusion? Author: Nancy E. Epstein MD

• Albert Einstein College of Medicine, Bronx, NY, USA• Publication: Surgical Neurology

• Left Ventricular Assist Devices: An Innovative Approach to Decrease Infections Using a Silver Contact Dressing Author: Joan Lerner Selekof BSN RN CWOCN

• University of Maryland Medical Center, Baltimore, MD, USA• Presented at: Mid Altantic Region Wound Ostomy and Continence Nurses Annual Conference, 2010

• Healing Chronic, Ischemic, Infected Saphenous Vein Harvest Sites in the Legs with Silver Plated Cloth and Allograft Dermal Regenerative Matrix

Authors: Stanley Carson MD FACS, Eric Travis DPM, Carol Ajifu PT, DIana To MPT

• Silver-Based Dressings for the Reduction of Surgical Site Infection: Review of Current Experience and Recommendation for Future Studies

Authors: Elia Charbel Abboud MD, Judson C. Settle MD, Timothy B. Legare MD, Jorge E. Marcet MD, David J. Barillo MD, Jaime E. Sanchez MD

• University of South Florida, Tampa, FL, USA• Publication: BURNS: The Journal of the International Society of Burn Injuries

Page 6: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated

618 W. Patrick St., Frederick, MD 21701 Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Exhibit B -Silverlon Life Saver Discs

Page 7: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon.com | 888.508.2872 or 630.232.2510

LC-SMM-64 Rev B

SILVERLON® Lifesaver™ IV Catheter Discs are an antimicrobial dressing with a unique permanent silver-plated metallic surface ideal for IVs, central lines and pin sites. Utilizing a large reservoir of silver ions, Lifesaver Discs continuously deliver an effective level of silver ions in the dressing for up to 7 days.

SILVERLON® LIFESAVER™ IV CATHETER DISCS

ERADICATE MRSA IN AS LITTLE AS 4 HOURS

Silverlon® Lifesaver™ IV Catheter Dressing 1” 4.0mm I.D.

CT
Highlight
Page 8: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon.com | 888.508.2872 or 630.232.2510

© Argentum Medical, LLC • All Rights Reserved. LC-SMM-64 Rev B

MIC

ROBI

AL C

OU

NTS

1

HOURS

10,000

1,000,000100,000

1,000100

10

10,000,000

1.0 2.0 3.0 4.0 5.0 6.0 7.0

IN VITRO TEST DATASILVERLON® MRSA and PSEUDOMONAS KILL RATE

MRSA CountsPseudomonas Counts

9,000,000 4,000,000

8,250,000 2,600,000270,000

500

BACTERIAL SPECIES

Staphylococcus aureus MRSA ATCC 33591

Pseudomonas aeruginosa ATCC 9027

0.0 Hr

8,250,000

9,000,000

0.5 Hr

2,600,000

4,000,000

1.0 Hr

270,000

0

2.0 Hr

500

0

4.0 Hr

0

0

6.0 Hr

0

0

24.0 Hr

0

0

Time and CFU/ml

PERFORMANCESilverlon has been studied in multiple specialties, including an independent, peer-reviewed published study covering over 60,000 central line days. To view complete studies, visit Silverlon.com.

POWERLifesaver™ Catheter Discs are effective against a broad spectrum of pathogens and contain up to 100 times more silver than impregnated silver dressings.

SPEEDSILVERLON® produces a broad spectrum antimicrobial effect that rapidly kills pathogens in the dressing, including MRSA and Pseudomonas, in as little as four hours.

SILVERLON® HAS AN ANTIMICROBIAL EFFECT WITHIN 2 HOURS AGAINST MRSA IN THE DRESSING, WITH ERADICATION IN 4 HOURS.

IVCD-MINI IVCD-15 IVCD-40 IVCD-70

IVCD-15-85

Catheter 5/8” Dressing

1.5mm I.D.

Catheter 1” Dressing1.5mm I.D.

Catheter 1” Dressing4.0mm I.D.

Catheter 1” Dressing7.0mm I.D.

Catheter 1.5” Dressing8.5mm I.D.

CT
Highlight
CT
Highlight
Page 9: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated

618 W. Patrick St., Frederick, MD 21701 Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Exhibit C-Silverlon Performance Surgical Dressing

Page 10: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon.com

68 Year Old FemaleTotal Knee Arthroplasty2 Days Post Op

Actual SILVERLON® Wound

SILVERLON® PERFORMANCE IN A SURGICAL DRESSING

Page 11: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

SILVERLON® DRESSINGS PROVIDE VISIBLE RESULTS.

PERFORMANCEWith SILVERLON®, you’ll find a wide range of independent, peer-reviewed, published clinical studies across multiple specialties.

POWERSILVERLON® Wound Dressings contain more metallic silver than any other dressing.

SPEEDSILVERLON® produces a broad spectrum antimicrobial effect that rapidly kills microorganisms, eradicating MRSA in the dressing in as little as 4 hours and keeps working for up to 7 days.

OTHER “SILVER” DRESSINGS

SILVER IMPREGNATED DRESSINGS• May have as little as 1/50th as much silver as SILVERLON®

• Silver layer is not in patient contact• Typically backed by in vitro data only

SILVER NANOCRYSTAL DRESSINGS• Typically 1/5th the silver of SILVERLON®1

• Staining and stinging can occur• Increased bioburden

1Steve Thomas PhD. MRSA (Metchicillin-Resistent Staphylococcus Aureus) and The Use of Silver Dressings: Overcoming Bacterial Resistance, WorldWide Wounds Nov. 2004, Revision: 1.1

SILVERLON® DRESSINGS CONTAIN MORE METALLIC SILVER THAN OTHER SILVER DRESSINGS

PROPRIETARY NAME

Ag Content(mg/100cm2)

SILVERLON® 546.00

Calgitrol Ag 141.00

Acticoat 104.00

Contreet Foam 85.00

Contreet Hydrocolloid 32.00

Aquacel Ag 8.30

SilvaSorb 5.30

Actisorb Silver 220 2.70

Urgotul SSD (SSD content 3.75%)

Arglaes powder 6.87mg/gram

58 Year Old FemaleTotal Hip ArthroplastySILVERLON® Dressing / 2 Days Post-Op

53 Year Old Female w/DiabetesTotal Hip ArthroplastySILVERLON® Dressing / 2 Days Post-Op

69 Year Old Female w/DiabetesTotal Knee ArthroplastySILVERLON® Dressing / 14 Days Post-Op

Page 12: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

MIC

ROBI

AL C

OU

NTS

1

HOURS

10,000

1,000,000100,000

1,000100

10

10,000,000

1.0 2.0 3.0 4.0 5.0 6.0 7.0

IN VITRO TEST DATASILVERLON® MRSA and PSEUDOMONAS KILL RATE

MRSA CountsPseudomonas Counts

9,000,000 4,000,000

8,250,000 2,600,000270,000

500

BACTERIAL SPECIES

Staphylococcus aureus MRSA ATCC 33591

Pseudomonas aeruginosa ATCC 9027

0.0 Hr

8,250,000

9,000,000

0.5 Hr

2,600,000

4,000,000

1.0 Hr

270,000

0

2.0 Hr

500

0

4.0 Hr

0

0

6.0 Hr

0

0

24.0 Hr

0

0

Time and CFU/ml

SILVERLON® HAS AN ANTIMICROBIAL EFFECT WITHIN 2 HOURS AGAINST MRSA IN THE DRESSING, WITH ERADICATION IN 4 HOURS*.

*Citation: 510(k) K122817, page 174 of 379.

WHAT MAKES SILVERLON® DRESSINGS UNIQUE?

SILVERLON® silver plated nylon technology offers many unique advantages over other silver dressings

• Sustainable – every SILVERLON® dressing can be used for up to 7 days• No increase in bioburden• No staining

SILVERLON® Surface Surface magnified

SURGICAL SITE INFECTIONS ARE A CRITICAL PROBLEM.

In a Cleveland Clinic study2, 75% of all Orthopedic readmissions were for infections and wound complications. Average additional hospital stay was 4.9 days.

In a Mayo Clinic study3, 32% of hip arthroplasty studies received post-op antibiotics (oral or IV).

In a Duke Infection Control Network study4, the average cost to treat a MRSA infection across 7 hospitals was $61,000.

2Mesko, Nathan W.; Kovacevic, David; Bachmann, Keith; Trihas, Deana; Lograsso, Mary Ellen; Froimson, Mark I. Thirty Day Orthopedic and Rheumatologic Re-Admissions: Retrospective Analysis at a Tertiary Care Medical Center. Presented at the Mid-America Orthopaedic Association 30th Annual Meeting 2012, Bonita Springs, FL3Novais, EduardoH.; Sierra, Rafael J.; Potter, G. David; Trousdale, Robert T. Higher Complication Rate in Obese Than Non-Obese Patients After Periacetabular Osteotomy Presented at the Mid-America Orthopaedic Association 30th Annual Meeting 2012, Bonita Springs, FL4Anderson, Deverick J.; Kay, Keith S.;Chen, Luke F.; Choi, Yong; Sloan, Richard; Sexton, Daniel J. Clinical and Financial Outcomes Due to Methicillin Resistant Staphylococcus Aureaus Surgical Site Infection: A Multi-Center Matched Outcomes Study PLoS One, Volume 4:12, December 2009

Page 13: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Independent, peer-reviewed and published clinical studies suggest SILVERLON® Island Dressings can be an important element in wound care and control of wound bacteria within the dressing may help reduce the risk of wound infection.

Please note that these studies may involve findings that exceed the claims currently cleared by the FDA for the product. Argentum Medical, LLC is not intending to make performance claims about its product. The intent is to disseminate the scientific literature on these products. We encourage you to read these studies to understand the strengths and limitations of the data. The actual intended use statements cleared by the FDA for these products are set forth below. For some claims, Argentum is seeking to broaden the indications with the FDA in the future using data, such as these studies, to provide the substantiation.

SILVERLON® dressings have been tested in vitro and found effective against microorganisms such as: Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococcus (VRE), Staphylococcus epidermidis, Escherichia Coli (E. coli), Shigella sonnei, Pseudomonas aeruginosa, Pseudomonas cepacia, Pseudomonas maltophiliaa, Acinetobacter calcoaceticus, Enterobacter cloacae, Salmonella typhimurium, Salmonella typhi, Enterococcus sp., Serratia marcescens, Listeria monocytogenes, Enterobacter cloacae, Staphylococcus, Streptococcus, Group B Streptococcus, Candida albicans, and Aspergillus niger.

INDICATIONSOVER-THE-COUNTER INDICATIONSLocal management of superficial wounds, minor burns, abrasions and lacerations.

RX USEUnder the supervision of a healthcare professional, SILVERLON® Island Wound Dressings are intended for up to 7 days of use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

SILVERLON® Island Wound Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the SILVERLON® Island Wound Dressing may help reduce the risk of wound infection and support the body’s healing process. SILVERLON® Island Wound Dressings may be used for the management of painful wounds. SILVERLON® Island Wound Dressings non-adherent wound contact layer reduces pain during dressing changes, and evaporation of moisture in the dressing may soothe the wound.

CONTRAINDICATIONSSILVERLON® Dressings should not be used on patients with 3rd degree burns or with known sensitivity to silver or nylon. For complete Instructions for Use, please visit Silverlon.com.

• Use of Silver Nylon Dressing Following Total Hip and Knee Arthroplasty Decreases the Postoperative infection Rate Ashley J. Tisosky Md, Otatade Iyoha-Bello BSc, Nicholas Demosthenes BA, Giovanni Quimbayo MD, Tara Coreanu BSc, Ayesha Abdeen MD FRCSC Harvard Combined Orthopaedic Residency Program, Massachusetts General Hospital, Boston, MA, USA

• The Use of Silver Nylon in Preventing Surgical Site Infections Following Colon and Rectal Surgery Beth Krieger MD, Donald M. Davis MD, Jaime E. Sanchez MD, James J. Mateka, Valentine N Nfonsam MD, Jared C. Frattini MD, Jorge E. Marcet MD St. John’s Health Center, Springfield, MO

• Reduction in Central Line-Associated Bloodstream Infections Correlated With the Introduction of a Novel Silver-Plated Dressing for Central Venous Catheters and Maintained for 6 Years Rachel Karlnoski PhD, Elia Charbel Abboud MD, Peggy Thompson BSN CIC FAPIC, Asa Z. Oxner MD, John T. Sinnott, MD FACP, Jorge E. Marcet MD FACS FASCRS Tampa General Hospital, Tampa, FL, USA

• A Clinical Trial to Investigate the Effect of Silver Dressings on Mediastinitis Rates in Postoperative Cardiac Sternotomy incisions Roger Huckfeldt MD FACS, Clyde Redmond MD, Debbie Mikkelson BSM, Philip J. Finley MS, Cindy Lowe BS CCRP, Jennifer Robertson RN St. John’s Regional Health Center, Springfield, MO, USA

• Do Silver-Impregnated Dressings Limit Infections After Lumbar Laminectomy with Instrumented Fusion? Nancy E. Epstein MD, Albert Einstein college of Medicine, Bronx, NY, USA

MULTIPLE CLINICAL STUDIES...

Silverlon.com | 888.508.2872 or 630.232.2510

© Argentum Medical, LLC • All Rights Reserved. LC-SMM-02-E

Page 14: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated

618 W. Patrick St., Frederick, MD 21701 Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Exhibit D -Advanced Wound Care & Burn Dressing

Page 15: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Advanced Wound Careand Burn Dressings

Page 16: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

What Makes Silverlon® Dressings Unique?Silverlon® Nylon Dressings Have a Permanently Plated Metallic Surface

Silverlon® Surface

Magnified

PROPRIETARY NAME Ag CONTENT (mg/100cm2)

Silverlon® 546

Calgitrol Ag 141

ActicoatContreet Foam

104

Contreet Hydrocolloid

85

Aquacel Ag

32

SilvaSorb

5.3

Actisorb Silver 220

2.7

Urgotul SSD (SSD content 3.75%)

Arglaes powder

6.87mg/gram

8.3

Silverlon® wound dressings contain more metallic silver than many other dressings(1)

1 Steve Thomas PhD. MRSA(Metchicillin-Resistant Staphylococcus Aureus) and The Use of Silver Dressings: Overcoming Bacterial Resistance, WorldWide Wounds Nov.2004, Revision:1.1

Silverlon® Safe. Strong. Simple.

Simple.• Wide variety of product groups

based on a single technology platform

• If you know how to use one Silverlon® dressing, you know how to use them all

Safe.• Silverlon® has been shown to be

effective against MRSA, Pseudomonas and E. Coli in the dressing

• Does not deposit metal crystals into the wound

• No staining or stinging

Strong.• Up to 50 times the silver of

many impregnated dressings1

• Continuous ion action for up to 7 days

Silverlon® has an antimicrobial effect within 2 hours against MRSA in the dressing, with eradication in 4 hours.

Micro

bial C

ount

s

Silverlon® MRSA and Pseudomonas Kill Rates

10,000,000

1,000,000

100,000

10,000

1,000

100

10

1

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0

Hours

MRSA Counts

Log R

educ

tions x

x

x x

8,250,000

2,600,000

270,000

500

Pseudomonas Counts

xx

x

Micro

bial C

ount

s

Silverlon® MRSA and Pseudomonas Kill Rates

10,000,000

1,000,000

100,000

10,000

1,000

100

10

1

0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0

Hours

MRSA Counts

Log R

educ

tions x

x

x x

8,250,000

2,600,000

270,000

500

Pseudomonas Counts

xx

x

Page 17: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

1 Steve Thomas PhD. MRSA(Metchicillin-Resistant Staphylococcus Aureus) and The Use of Silver Dressings: Overcoming Bacterial Resistance, WorldWide Wounds Nov.2004, Revision:1.1

Silverlon® Advanced Wound Care DressingsSilverlon® can be an important element in wound care, and control of wound bacteria in the dressing may help reduce the risk of wound infection.

Silverlon® Advanced Wound Care Dressings are indicated for management of a wide variety of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, traumatic and surgical wounds, 1st and 2nd degree burns, and donor and graft sites.

SILVERLON® WOUND CONTACT DRESSINGS Silverlon® Wound Contact Dressings are designed to be used for up to 7 days with any other secondary dressing of choice to either absorb or donate moisture. Separating the silver layer from the secondary dressing reduces costs by allowing the clinician to throw away as many inexpensive absorbent dressings as needed while the Silverlon® dressing stays in place for up to 7 days. SILVERLON® WOUND PACKING STRIPS Designed for packing into open or “tunneling” wounds, Silverlon® WPS can be used continuously for up to seven days, and are easily removed in one piece. SILVERLON® CALCIUM ALGINATE DRESSINGS Silverlon® Calcium Alginate Dressings are a sterile, non-woven pad composed of a High M (manuronic acid) alginate and a silver nylon contact layer. The silver ions provide an antimicrobial action in the dressing, while the dressing absorbs exudates and maintains a moist wound environment. Unlike some alginates, Silverlon® is designed specifically for intact removal and eliminates the need to “pick” for remnants left in the wound.

Silverlon® Burn DressingsSilverlon® burn dressings have been shown to be effective in the management of burns. Long the choice of the U.S. Army for burn and blast injuries, Silverlon® dressings contour easily to wound surfaces and provide increased range of motion. Silverlon® specialty burn dressings offer quick and easy application, and the seven day efficacy of Silverlon® dressings can mean fewer dressing changes and greater patient comfort.

SILVERLON® BURN GLOVESOpen-finger, oversized gloves are ideal for use immediately after acute injury or post-surgery for both partial and full thickness burns. Quick and easy application to fingers and hand allows immediate, increased range of motion. Offered in 6 sizes to fit virtually any hand. Designed 20% oversized to allow for soft tissue swelling and easy removal without sheering of fragile split thickness skin grafts.

SILVERLON® BURN WRAPS AND DIGIT SLEEVESExtremely flexible and elastic wrap provides mild compression and is ideal for use over large and contoured surface areas. Wrap offers great comfort and is easy to apply. Ideal for burns, grafts, and donor sites. Silverlon® digit sleeves provide circumferential protection, mild pressure, and complete freedom of movement. Can be trimmed to fit any digit.

Page 18: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon® Digit Sleeves

Silverlon® Fenestrated Dressings

Silverlon® Wound Contact Dressings

Silverlon® Safe. Strong. Simple.

For more information on dressings designed specifically for Surgical Site and Catheter- related applications, please see your Silverlon® representative or visit silverlon.com.

Silverlon® dressings are available in multiple shapes and sizes, providing a single technology for surgical, burn, and chronic and acute wounds. Similar application procedures apply to all dressing types, simplifying training and compliance across departments.

Silverlon® Wound Packing Strips

Silverlon® Calcium Alginate Dressings

Silverlon® Burn Gloves

Silverlon® Digit Sleeves

Silverlon® Fenestrated Dressings

Silverlon® Wound Contact Dressings

Silverlon® Burn Wraps

Argentum Medical and Silverlon® are registered trademarks of Argentum Medical, LLC.

Argentum Medical 2571 Kaneville Court Geneva, IL 60134 silverlon.com

Phone: 888-551-0188/630-232-2507 Fax: 888-558-9923/630-232-8005

Silverlon® Wound Packing Strips

Silverlon® Calcium Alginate Dressings

Silverlon® Burn Gloves

Silverlon® Burn Wraps

Silverlon® Burn Contact Dressings

PRODUCT # SIZE

NPD-22 2” x 2”NPD-45 4” x 5”NPD-58 5” x 8”NPD-512 5” x 12”NPD-1212 12” x 12”NPG-L NPD Glove (Large)

PRODUCT # SIZE

WCD-22 2” x 2”WCD-44 4” x 4.5”WCD-412 4” x 12”WCD-1012 10” x 12”WCD-466 4” x 66”

PRODUCT # SIZE

WPS-112 1” x 12”WPS-124 1” x 24”

PRODUCT # SIZE

ABG-XS to XXL XS, S, M , L, XL, XXL

PRODUCT # SIZE

BWD-466 4” x 66”BWD-6108 6” x 108”

PRODUCT # SIZE

BCD-44 4” x 4”BCD-48 4” x 8”BCD-816 8” x 16”BCD-1616 16” x 16”BCD-2424 24” x 24”

BCD-CDM Chest Torso Medium

25.5” x 26”

BCD-CDL Chest Torso Large

30” x 25.5”

PRODUCT # SIZE

DS-112 1.5” x 12”

PRODUCT # SIZE

CA-22 2” x 2”CA-475 4” x 4.75”CA-48 4” x 8”

CA-7512 0.75” x 12” (rope)

CA-812 8” x 12”

LC-SMM-01-C

Page 19: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

L1 Enterprises, Incorporated

618 W. Patrick St., Frederick, MD 21701 Tel: 301.698.5798 FAX: 443.927.7277

L1 Enterprises, Incorporated

Exhibit E -Silverlon Flex Tape Dressing

Page 20: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon.com

SILVERLON® FLEXIBLE FOAM TAPE DRESSINGS

SILVERLON® performance in a 7-day

shower-proof dressing ideal for

surgical incisions, including

total knee and total

hip arthroplasty.

PATIENT-FREINDLY ADHESIVE

Page 21: MEDICAL EQUIPMENT, SUPPLIES, & SERVICES Literature · 2020. 1. 19. · 5 Department of Orthopaedic Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA,

Silverlon.com | 888.508.2872 or 630.232.2510

© Argentum Medical, LLC • All Rights Reserved. LC-SMM-08-C

MIC

ROBI

AL C

OU

NTS

1

HOURS

10,000

1,000,000100,000

1,000100

10

10,000,000

1.0 2.0 3.0 4.0 5.0 6.0 7.0

IN VITRO TEST DATASILVERLON® MRSA and PSEUDOMONAS KILL RATE

MRSA CountsPseudomonas Counts

9,000,000 4,000,000

8,250,000 2,600,000270,000

500

BACTERIAL SPECIES

Staphylococcus aureus MRSA ATCC 33591

Pseudomonas aeruginosa ATCC 9027

0.0 Hr

8,250,000

9,000,000

0.5 Hr

2,600,000

4,000,000

1.0 Hr

270,000

0

2.0 Hr

500

0

4.0 Hr

0

0

6.0 Hr

0

0

24.0 Hr

0

0

Time and CFU/ml

SILVERLON® HAS AN ANTIMICROBIAL EFFECT WITHIN 2 HOURS AGAINST MRSA IN THE DRESSING, WITH ERADICATION IN 4 HOURS*.

*Citation: 510(k) K122817, page 174 of 379.

PRODUCT # SIZE

ID-49 4” x 9”ID-411 4” x 11”ID-413 4” x 13”ID-512 4.5” x 12”ID-515 4.5” x 15”

SILVERLON® FLEXIBLEFOAM TAPE DRESSINGS

SILVERLON® DRESSINGS PROVIDE VISIBLE RESULTS.

PERFORMANCE• Patient-friendly adhesive withflexiblefoamtape•Clearwindowallowsunobstructed visualization of the wound pad• No staining or stinging of the wound• Peer-reviewed results

POWER• Up to 50 times the silver of many impregnated dressings1

•Deliversantimicrobialsilverions in the dressing, when activated bymoisture,forupto7days• Patient can shower with the dressing in place

SPEED• Reduced dressing changes2

•Multipledressingtypesbased on a single technology platform• Eradicates MRSA in the dressing within 4 hours (data on file)

1Steve Thomas PhD. MRSA (Metchicillin-Resistent Staphylococcus Aureus) and The Use of Silver Dressings: Overcoming Bacterial Resistance, WorldWide Wounds Nov. 2004, Revision: 1.12As compared to dressings requiring more than one dressing change every 7 days

68 Year Old FemaleTotal Hip ArthroplastySILVERLON® Dressing / 2 Days Post-Op

69 Year Old Female w/DiabetesTotal Knee ArthroplastySILVERLON® Dressing / 14 Days Post-Op