MANAGING INS INFECTION RISK TYRX Neuro Absorbable
Antibacterial Envelope

A NEW STANDARD FOR REDUCING INFECTION IN HIGH-RISK PATIENTS

Both the TYRX™ Neuro Absorbable Antibacterial Envelope and the TYRX™ Cardiac Absorbable Antibacterial Envelope for cardiac implantable electronic devices (CIEDs) are designed to help reduce infection, and they share many of the same features.

In cardiac cases, bacterial infection is one of the most common causes of complications, and the standard antibiotic prophylaxis have significant deficiencies when used as a single agent to prevent infection.1-2

The TYRX Absorbable Antibacterial Envelope helps reduce infection in high-risk patients and is more effective when combined with the standard treatment.3

The Problem. The Impact. The Solution.

Infections are Increasing at a Faster Rate than CIED Implants1

Change in CIED implants and infections between 1993-2008

Contributing factors for this increase:

  • Older patients receiving devices
  • More patient co-morbidities
  • Longer procedures
  • Changing mix of ICDs
  • Increasing number of pulse generator replacements and upgrades
  • Revisions
  • More resistant S aureus & coagulase (-) Staphylococcus species (e.g., S epidermidis)

Standard Antibiotic Prophylaxis Is Falling Short

Bacteria Responsible for Many CIED Infections

Typically, the same anti-infective measures are used for all patients regardless of their risk of infection.17-18 Pre-operative IV antibiotic prophylaxis is routinely given one hour before first incision. Ninety percent of patients receive cephalosporin and/or vancomycin.

Perioperatively, the pocket is typically irrigated with antibiotic agents.

Approximately 45% of the time, oral antibiotics are prescribed after the procedure. IV antibiotics may be administered for 24 hours after the initial implant.

  • Cefazolin and vancomycin can have important clinical limitations when used as a single agent to prevent CIED infection.2
  • Coagulase(-) staphylococcus species and S aureus are responsible for about 70% of CIED infections and are increasingly resistant to methicillin.10-16

The TYRX Envelope Offers More Coverage Combined with Standard Treatment3

  • Cefazolin and vancomycin are rarely used in combination and have important clinical deficiencies when used as a single agent to prevent CIED Infections.2
  • Both have activity against gram (+) organisms; there is substantial overlap.2
  • Neither has a strong profile against gram (-) organisms.2
  • Gentamicin has variable activity against coagulase (-) Staphylococcus , MSSA, and MRSA, and may be effective in some infections, but not reliably effective in others.2
  • Topical ionic silver does not have activity against coagulase (-) Staphylococcus and has no data to support coverage in M catarrhalis or Corynebacterium jeikeium.19-22

Adjunctive Antibiotic Prophylaxis with TYRX Helps Prevent Infection2,19-25

Adjunctive Antibiotic Prophylaxis with TYRX Helps Prevent Infection

1

Greenspon A et al. J Am Coll Cardiol. 2011;58(10):1001-1006.

2

The Sanford Guide to Antimicrobial Therapy. Web Edition. 2015: Antimicrobial Therapy Inc.; Hyde Park, VT

3

Mittal S et al. Heart Rhythm. 2014; 11(4):595-601.

4

Sohail MR et al. PACE. 2015;38(2):231-239. 

5

Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services Inpatient Prospective Payment System (IPPS) Final Rule FY13. 

6

Bloom HL et al. Pacing Clin Electrophysiol. 2011; 34(2):133-142. 

7

Kolek MJ et al. J Cardio Electrophysiol. 2015;26(10):1111-1116. 

8

Shariff N et al. J Cardio Electrophysiol. 2015;26(10):783-789.

9

Henrikson CA et al. JACC EP 2017; 3 (10):1158-1167. 

10

Wisplinghoff H et al. CID. 2004;39(3):309-317.

11

NNIS System Report. Am J Infect Control. 2004;32(8):470-485.

12

Klug D et al. Circulation. 2007;116(12):1349-1355.

13

Lekkerkerker JC et al. Heart. 2009;95(9):715-720.

14

de Oliveira JC et al. Circ Arrhyth Electrophysiol. 2009;2(1):29-34.

15

D a Costa A et al. Circulation. 1998;97(18):1791-1795.

16

Chua J et al. Ann Intern Med. 2000;133(8):604-608.

17

MEDACorp. Survey of 42 EPs and 30 cardiac lab supervisors, 2007. Sponsored by TYRX, Inc.

18

Easton Assoc. Survey of 24 EPs, 6 EP lab Mgrs. And RNs, 2008. Sponsored by TYRX, Inc.

19

Lansdown A et al. Issues in Toxicology. 2010; 5.3:123.

20

Percival SL et al. Wound Repair Regeneration. 2011; 19(6); 769-770. Online publication.

21

Argentum Medical. Silverlon® Product Brochure.

22

Townsend Letter for Doctors & Patients. April 2006; Issue 273: 66-72.

23

Zinner SH et al. J Infect Dis. 1981;144(4):365-371.

24

Darouiche RO et al. Int J Antimicrob Agents. 1995;6(1):31-36.

25

Segreti J et al. Diagn Microbiol Infect Dis. 1989;12(3):253-255.