CLINICAL OUTCOMES TYRX Neuro Absorbable
Antibacterial Envelope

70% to 100% Reduction in Device Infection

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.

Clinical data for the TYRX Cardiac Envelope show a reduced rate of infections among high-risk patients who received a CIED.

The TYRX Antibacterial Envelope helps reduce CIED infections in high-risk patients3,5,6

The TYRX Antibacterial Envelope helps reduce CIED infections in high-risk patients

Clinical Studies Demonstrate the Benefit of TYRX Envelopes

pdf COMMAND Study: Published in PACE, 2011 (.pdf)

The COMMAND study demonstrated that there were fewer infections in a study cohort that received the TYRX Envelope than in certain historical control cohorts that did not receive the TYRX Envelope.1 For this study, 642 patients enrolled at 10 U.S. academic, community, and VA medical centers with 1.9 +/- 2.4 months follow-up. All patients met criteria for analyses. The COMMAND study found a 70% reduction in infections in high-risk patients compared to some previous studies.

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pdf Vanderbilt Study: Published in J Cardio Electrophysiol, 2015 (.pdf)

The Vanderbilt study found a 90% to 100% reduction in ICD infection in high-risk patients who received a TYRX Envelope compared to those who did not.2 This study compared the incidence of CIED infection in 488 patients with recognized risk factors for CIED infection (who had a CIED implanted with the TYRX Absorbable or TYRX Non-Absorbable Envelope) to a control cohort of 638 patients, matched using propensity score matching for the presence of these recognized risk factors for infection (who had a CIED implanted without an TYRX Envelope).

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pdf Valley Health System Study: Published in Heart Rhythm, 2014 (.pdf)

The Valley Health study concluded that the TYRX Envelope reduced pocket infections by 79% and 100% in the medium and high-risk groups, respectively.2 Two cohorts of patients who underwent CIED procedures were identified: 1,651 patients before introduction of the TYRX Envelope to the facility (Jan 2007 – Oct 2009) and 1,240 patients after introduction (Oct 2009 – Sept 2011), including 275 patients who received the TYRX Envelope. These groups were matched using propensity score matching.

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pdf Citadel and Centurion Clinical Study: Published in JACC EP, 2017; Citadel and Centurion Economic Study: Published in J Am Coll Cardio, 2017  (.pdf)

The Citadel and Centurion clinical study found a 73% to 90% reduction in ICD and CRT infection in high-risk patients who received a TYRX Envelope compared to those who did not. This was a prospective, multi-center clinical study to evaluate major device infection and mechanical complication rates in the 12 months following implantation, in patients at high-risk for CIED infection who had their CIED implanted with a TYRX Envelope. Study patients were enrolled at 55 U.S. centers and were at high-risk for infection because they were undergoing a replacement procedure with an ICD (Citadel), or CRT device (Centurion).

The Citadel and Centurion Economic Study found that the TYRX Antibacterial Envelope was associated with large reductions in hospital costs. The study objective was to quantify the hospital perspective economic impact associated with TYRX Antibacterial Envelope use, based on the reduction in CIED infections demonstrated in the Citadel and Centurion Clinical Study. Results demonstrated that per the study population of 1,129 patients, use of the TYRX Antibacterial Envelope was associated with 20 fewer CIED infections (5 vs. 25). The total TYRX cost of $1,129,000 was offset by a $1,644,975 reduction in total CIED-related hospital costs, for a net cost savings of $515,975 or $457 per patient.

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pdf UPMC Study: Published in J Cardio Electrophysiol, 2015 (.pdf)

A single-center, retrospective cohort study with the University of Pittsburgh Medical Center (UPMC) concluded that CIED infections result in significant patient and healthcare system burden, high costs, long length of stays, and higher mortality rates. Use of the TYRX Envelope as a standard of care was associated with a significantly lower rate of CIED infections.3

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Clinical Data Shows Lower Rate of Infection and Lower Costs

Strong clinical data associates the use of the TYRX Antibacterial Envelope with a significantly lower rate of cardiac implantable electronic device (CIED) infections — infections that are both costly to the healthcare system and pose a significant mortality risk to patients.

Economic Impact of CIED Infection

Economic Impact of CIED Infection
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The COMMAND, C&C (Citadel & Centurion), Valley, Vanderbilt (Non-Absorbable) and UPMC Studies were performed utilizing the TYRX™ Non-Absorbable Antibacterial Envelope.

†

The Vanderbilt (Absorbable) Study was performed utilizing the Absorbable TYRX™ Absorbable Antibacterial Envelope.

1

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

2

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

3

Shariff N et al. J Cardio Electrophysiol. 2015. Online publication.

4

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

5

Sohail MR et al. Arch Intern Med. 2011;171(20):1821-1828.