CeraShield™ ETT

[vc_section][vc_row][vc_column][vc_custom_heading text=”Next standard of care in Hospital Acquired Infection (HAI) prevention” font_container=”tag:h2|font_size:24|text_align:left” use_theme_fonts=”yes” css=”.vc_custom_1673030091452{margin-bottom: 10px !important;}” el_class=”weight100″][vc_custom_heading text=”CeraShield™” font_container=”tag:h1|font_size:85|text_align:left|color:%2312afa3|line_height:100px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:100%20light%20regular%3A100%3Anormal” css=”.vc_custom_1673119185243{margin-bottom: 10px !important;}” el_id=”n8-header-h1″][vc_custom_heading text=”Biofilm-resistant endotracheal tube” font_container=”tag:p|font_size:22px|text_align:left|color:%234f4e4e|line_height:26px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:500%20bold%20regular%3A500%3Anormal” css=”.vc_custom_1673034747057{margin-bottom: 10px !important;}”][vc_custom_heading text=”Designed to reduce ventilator associated respiratory infections (VARI)
and significantly lower overall cost of care” font_container=”tag:p|font_size:18px|text_align:left|color:%23757575|line_height:22px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:400%20regular%3A400%3Anormal” css=”.vc_custom_1673119568818{margin-bottom: 10px !important;}”][vc_single_image image=”2386″ img_size=”full” alignment=”center” el_id=”n8-cerashield-img”][vc_btn title=”Interested in Evaluating?” shape=”square” size=”lg” align=”left” link=”url:https%3A%2F%2Fwww.n8medical.com%2Fett-survey%2F|title:CeraShield%20Endotracheal%20Tube%20Survey” el_class=”n8-brochure-button”][vc_btn title=”Download Brochure” shape=”square” size=”lg” align=”left” link=”url:https%3A%2F%2Fwww.n8medical.com%2Fwp-content%2Fuploads%2F2023%2F01%2FCeraShield-TriFold-Brochure-forWeb-v7-mm.pdf” el_class=”n8-brochure-button”][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_custom_heading text=”Medical device-associated biofilms pose a serious threat to human health and lead to nosocomial infections” font_container=”tag:h2|font_size:28px|text_align:left|color:%2377cad4|line_height:32px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_custom_heading text=”New strategies are urgently needed” font_container=”tag:p|font_size:48px|text_align:left|color:%234f4e4e|line_height:56px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:100%20light%20regular%3A100%3Anormal” css=”.vc_custom_1673116978618{margin-bottom: 10px !important;}”][vc_column_text el_class=”n8-small-font”]Up to 80% of microbial infections in the human body involve biofilm formation, especially in hospital settings, which greatly promotes the incidence rate and mortality 1,2[/vc_column_text][vc_row_inner][vc_column_inner width=”1/2″][vc_column_text el_class=”colorE4515E”]Over 6 million potential deaths from nosocomial infections worldwide each year 3[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/4″][vc_single_image image=”2395″ img_size=”full”][/vc_column_inner][vc_column_inner width=”1/4″][vc_column_text el_class=”n8-small-font”]60–70% of nosocomial
infections are associated
with biomaterials or implants 4[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_row_inner content_placement=”middle”][vc_column_inner width=”1/2″][vc_column_text el_class=”n8-small-font”]Ordinary medical devices allow millions of pathogenic CFUs to grow within hours and act as a reservoir of infectious agents, leading to inflammation and infection.

The resistance of bacteria in biofilms to antibiotics can be 10–1,000X that of the corresponding planktonic cells. 5

The rates of horizontal plasmid transfer were several orders of magnitude higher in the biofilms
than in liquid cultures of the same organisms. 6[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”2402″ img_size=”full”][/vc_column_inner][/vc_row_inner][vc_row_inner][vc_column_inner][vc_column_text el_class=”n8-tiny-text”]1. Jamal, M.; Ahmad, W.; Andleeb, S.; Jalil, F.; Imran, M.; Nawaz, M.A.; Hussain, T.; Ali, M.; Rafiq, M.; Kamil, M.A. Bacterial biofilm and associated infections. J. Chin. Med. Assoc. 2018, 81, 7–11.
2. Khatoon, Z.; McTiernan, C.D.; Suuronen, E.J.; Mah, T.-F.; Alarcon, E.I. Bacterial biofilm formation on implantable devices and approaches to its treatment and prevention. Heliyon 2018, 4, e01067.
3. Gyawali B, Ramakrishna K, Dhamoon AS. Sepsis: The evolution in definition, pathophysiology, and management. SAGE Open Med. 2019;7:2050312119835043. Published 2019 Mar 21. doi:10.1177/2050312119835043.
4. Yasir, M.; Willcox, M.D.P.; Dutta, D. Action of Antimicrobial Peptides against Bacterial Biofilms. Materials 2018, 11, 2468.
5. Kisil, O.V.; Efimenko, T.A.; Gabrielyan, N.I.; Efremenkova, O.V. Development of antimicrobial therapy methods to overcome the antibiotic resistance of Acinetobacter baumannii. Acta Nat. 2020, 12, 34–45.
6. Rodney M. Donlan, Biofilm Formation: A Clinically Relevant Microbiological Process, Clinical Infectious Diseases, Volume 33, Issue 8, 15 October 2001, pages 1387–1392, https://doi.org/10.1086/322972.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_custom_heading text=”CeraShield™ biofilm-resistant coating works
to prevent infection and inflammation” font_container=”tag:h2|font_size:28px|text_align:left|color:%2377cad4|line_height:32px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_row_inner][vc_column_inner width=”1/2″][vc_column_text el_class=”n8-small-font” css=”.vc_custom_1673031881870{margin-bottom: 0px !important;}”]Ordinary ETT[/vc_column_text][vc_single_image image=”2408″ img_size=”full”][/vc_column_inner][vc_column_inner width=”1/2″][vc_column_text el_class=”n8-small-font” css=”.vc_custom_1673031888464{margin-bottom: 0px !important;}”]CeraShield™ Biofilm-Resistant ETT[/vc_column_text][vc_single_image image=”2409″ img_size=”full”][/vc_column_inner][/vc_row_inner][vc_column_text el_class=”n8-medium-font”]CeraShield™ coating mimics the activity of the human body’s innate immune system, which does not induce antimicrobial resistance (AMR)[/vc_column_text][vc_row_inner content_placement=”middle”][vc_column_inner width=”1/2″][vc_column_text el_class=”n8-small-font”]Creates hydration layer that inhibits bacterial adhesion to the surface, creating a “moat” around the device.

The CeraShield™ coating’s net positive charge attracts the negatively-charged membranes of certain viruses, fungi, and bacteria.

As the CeraShield™ coating and pathogen get closer together, the CeraShield™ coating begins to permeabilize and depolarize the cell
membrane, leading to rapid cell death.[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”2410″ img_size=”full”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_custom_heading text=”Ventilator-associated pneumonia:
what is the real cost?” font_container=”tag:h2|font_size:28px|text_align:left|color:%2377cad4|line_height:32px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_row_inner content_placement=”middle”][vc_column_inner width=”1/2″][vc_column_text el_class=”n8-small-font”]Each added case of ventilator
respiratory infection adds between
$10,000–$50,000 (US). 7[/vc_column_text][vc_column_text el_class=”colorE4515E”]The total preventable cost worldwide is >$10 billion. 8[/vc_column_text][vc_custom_heading text=”9-13%” font_container=”tag:p|font_size:85px|text_align:left|color:%23e4515e|line_height:100px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:100%20light%20regular%3A100%3Anormal” css=”.vc_custom_1673032323787{margin-bottom: 0px !important;}”][vc_column_text]attributable risk of death 9[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”2417″ img_size=”full”][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_row_inner][vc_column_inner width=”1/2″][vc_single_image image=”2422″ img_size=”full”][vc_column_text]Approximately 50% of all critical care antibiotics are for treatment for VAP 9,11[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″][vc_single_image image=”2488″ img_size=”full”][vc_column_text el_class=”n8-tiny-text”]7. Tejerina E, Frutos-Vivar F, Restrepo MI, et al. Incidence, risk factors, and outcome of ventilator-associated pneumonia. J Crit Care 2006 Mar;21(1):56-65. 16616625.
8. Restrepo MI, Sibila O, Anzueto A. Pneumonia in Patients with Chronic Obstructive Pulmonary Disease. Tuberc Respir Dis (Seoul). 2018;81(3):187-197. doi:10.4046/trd.2018.0030.
9. Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU [published correction appears in Crit Care. 2016;20:29. Zai, Wendy [corrected to Ziai, Wendy]]. Crit Care. 2014;18(2):208. Published 2014 Mar 18. doi:10.1186/cc13775.
10. Rose L, Fraser IM. Patient characteristics and outcomes of a provincial prolonged-ventilation weaning centre: a retrospective cohort study. Can Respir J. 2012;19(3):216-220. doi:10.1155/2012/358265.
11. Petrosillo N, Capone A, Di Bella S, Taglietti F. Management of antibiotic resistance in the intensive care unit setting. Expert Rev Anti Infect Ther. 2010 Mar;8(3):289-302. doi: 10.1586/eri.10.7. PMID: 20192683.
12. Temsah MA, Al-Eyadhy AA, Al-Sohime FM, et al. Long-stay patients in pediatric intensive care units. Five-years, 2-points, cross-sectional study. Saudi Med J. 2020;41(11):1187-1196. doi:10.15537/smj.2020.11.25450.[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_row_inner][vc_column_inner width=”1/2″][vc_custom_heading text=”Introducing the proprietary Cerashield™ coated bacteria-resistant endotracheal tube” font_container=”tag:h2|font_size:28px|text_align:left|color:%2377cad4|line_height:32px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_column_text]By preventing biofilm, we can significantly prevent VAP and other adverse outcomes[/vc_column_text][vc_single_image image=”2486″ img_size=”full”][vc_column_text el_class=”n8-tiny-text”]*Girou, E., Buu-Hoi, A., Stephen, F. et al. Airway colonization in long-term mechanically ventilated patients. Intensive Care Med 30, 225-233 (2004). https://doi.org/10.1007/s00134-003-2077-4.

The CeraShield™ ETT is approved for marketing in Canada and Belize with other approvals pending. The CeraShield™ ETT is an investigational device in the United States.[/vc_column_text][/vc_column_inner][vc_column_inner width=”1/2″ css=”.vc_custom_1673033542971{margin-bottom: -185px !important;}”][vc_single_image image=”2426″ img_size=”full”][vc_column_text el_class=”n8-breakthrough”]Designated as “breakthrough device” by FDA[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space height=”100px”][vc_single_image image=”2432″ img_size=”full” el_id=”n8-table-graphic”][vc_custom_heading text=”Indication” font_container=”tag:h2|font_size:28px|text_align:left|color:%2377cad4|line_height:32px” google_fonts=”font_family:Roboto%3A100%2C100italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C700%2C700italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_column_text]The CeraShield™ endotracheal tube is to be used for airway
management in adult patients expected to be intubated ≥ 24 hours.

The CeraShield™ ETT consists of:

  • A standard adult cuffed ETT manufactured and sourced from
    Flexicare offered in sizes 7.0mm–8.5mm
  • A hydrophilic anti-fouling coating on the inner and outer lumens,
    and the inflatable cuff

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