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CLINICAL OUTCOMES TYRX Absorbable Antibacterial Envelope

70% to 100% Reduction in CIED Infection

The TYRX™ Absorbable Antibacterial Envelope helps reduce cardiac implantable electronic device (CIED) infections in high-risk patients.

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

Clinical Studies Demonstrate the Benefit of TYRX Envelope

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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The COMMAND study
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 recognised 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 recognised risk factors for infection (who had a CIED implanted without an TYRX Envelope).

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The Vanderbilt Study
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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Valley Health System Study
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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Citadel and Centurion Clinical Study
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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UPMC Study

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.

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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UPMC Study

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.

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

TYRX™ Cardiac Absorbable Antibacterial Envelope

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See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu

The envelope is intended to hold the following CIED securely to create a stable environment when implanted in the body at the following locations: Implantable Pulse Generator (IPG), Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Devices (CRT-P and CRT-D); implant locations are pectoral, abdominal, or flank (lateral to the body midline and superior to the gluteal) regions.

The envelope contains the ancillary medicinal substance ansamycin, which has been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of the device.

The envelope is contraindicated for use in patients with allergy or history of allergy to tetracyclines, ansamycin, or absorbable sutures; in patients with systemic lupus erythematosus (SLE) because minocycline has been reported to aggravate this condition; in contaminated or infected wounds.

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.