DUBLIN, July 26, 2021 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
announced new data from the landmark WRAP-IT study published in
Heart Rhythm, demonstrating a significantly lower infection
risk for patients who develop hematomas after cardiac implantable
electronic devices (CIEDs) when the TYRX™ Absorbable Antibacterial
Envelope (TYRX Envelope) is used at implant. The analysis showed an
82% reduction in major CIED infections among patients with the TYRX
Envelope who developed hematomas compared to patients in the
control group who developed hematomas.
An estimated 1.5 million patients worldwide receive a CIED every
year,1 with 1% to 4% of these patients developing
infections2 resulting in significant impacts on
mortality, quality of life, healthcare utilization, and cost to
global healthcare systems.3,4 Implant site
hematoma, which is localized bleeding outside of the blood vessels,
is a known complication of CIED procedures and can lead to
device-related infections. Previous randomized controlled studies
found a more than seven-fold risk of subsequent serious
device-related infections in patients who develop a
hematoma.5
The current WRAP-IT (Worldwide Randomized Antibiotic Envelope
Infection Prevention Trial) analysis evaluated the incidence and
consequences of hematomas and the association between TYRX Envelope
use, hematomas, and major CIED infections among study patients
(3,429 patients in control group; 3,371 patients in TYRX Envelope
group). Patients with hematomas occurring within 30 days after the
implant procedure were evaluated for subsequent infection risk. The
incidence of hematomas was 2.2% (151 patients) and was similar
among control and envelope patients.
The key findings, through 36 months of follow-up:
- In the control group, there was a greater than 11-fold increase
in the risk of major infection among patients with hematoma vs.
those without hematoma (13.1% vs. 1.6%; p<0.001).
- In envelope patients, the use of the TYRX Envelope reduced the
risk of major infection among patients with hematoma: an 82%
reduction in infection compared to control patients with hematoma
(2.5% vs. 13.1%; p=0.03).
"Procedure-related hematomas are associated with serious
consequences. This analysis sheds new light that these consequences
can be significantly mitigated with the TYRX Envelope," said
Rob Kowal, M.D., PhD., chief medical
officer of the Cardiac Rhythm Management business, which is part of
the Cardiovascular Portfolio at Medtronic. "We look forward to
additional data from WRAP-IT exploring the risk factors leading to
procedure-related hematomas."
Additional Data from WRAP-IT Highlights Patients at Risk for
Hematoma at Heart Rhythm 2021
The WRAP-IT trial has produced
more than 20 peer-reviewed manuscripts and abstracts to date, with
robust clinical evidence supporting the use of the TYRX Envelope.
During Heart Rhythm 2021, the Heart Rhythm Society's annual
scientific sessions, additional data from WRAP-IT will be unveiled:
"Antithrombotic Use and Risk of Hematoma During Cardiac Device
Procedures: Insights from the WRAP-IT Trial" will be presented from
1:30-1:40 p.m. ET July 28 (Abstract: B-PO01-038).
About the TYRX™ Absorbable Antibacterial Envelope
The
TYRX Envelope is an absorbable, single-use device that holds a
cardiac implantable electronic device or implanted neurostimulator.
It is designed to stabilize the device after implantation while
releasing antibacterial agents, minocycline and rifampin, over a
minimum of seven days.6 Constructed from a
multifilament, knitted absorbable mesh, the envelope is fully
absorbed by the body approximately nine weeks after
implantation.6,7
About the WRAP-IT Clinical Trial
WRAP-IT compared the
incidence of major infections in patients whose CIED implantation
included the TYRX Envelope (3,495) and patients whose procedure did
not (3,488), with follow up through 12 months. Primary results
published in The New England Journal of Medicine
demonstrated the TYRX Envelope reduced the risk of major infections
by 40% in patients with CIEDs and reduced pocket infections by 61%
when used as adjunctive therapy in addition to standard of care
infection-prevention strategies.8 The trial also
met its safety objective: the envelope did not increase the risk of
complications through 12 months. Economic analyses have
demonstrated the envelope's cost-effectiveness compared to
standard-of-care infection prevention strategies in
U.S.9 and European4 healthcare
systems.
The study population included patients receiving a new cardiac
resynchronization therapy defibrillator (CRT-D); and patients
receiving a replacement, system revision or generator upgrade of an
existing pacemaker, cardiac resynchronization therapy-pacemaker
(CRT-P), implantable cardioverter defibrillator (ICD) or CRT-D.
Patients with diabetes, previous history of infection, renal
failure, and/or congestive heart failure also are at higher risk
for CIED infections.
Based on the WRAP IT results, an international consensus
statement, supported by seven medical societies (including the
Heart Rhythm Society), recommends the TYRX Envelope for the WRAP IT
study population and for patients with high risk
factors.10
Cleveland Clinic named the Medtronic TYRX Envelope one of the
Top 10 Medical Innovations for 2020,11 and the TYRX
Envelope also was named a Fast Company World Changing Ideas
finalist in the Health category in 2021.12
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare
consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
1 Mond HG, Proclemer A. The 11th world survey of
cardiac pacing and implantable cardioverter-defibrillators:
calendar year 2009 — a World Society of Arrhythmia's project.
Pacing Clin Electrophysiol. 2011; 34: 1013-1027.
2 Tarakji KG, et al. Worldwide Randomized
Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT). Am Heart
J. 2016;180:12
3 Wilkoff BL, Boriani G, Mittal S, et al. Impact of
Cardiac Implantable Electronic Device Infection: A Clinical and
Economic Analysis of the WRAP-IT Trial. Circ Arrhythm
Electrophysiol 2020;13:e008280.
4 Boriani G, et al. Cost-Effectiveness Analyses of
an Absorbable Antibacterial Envelope for Use in Patients at
Increased Risk of Cardiac Implantable Electronic Device Infection
in Germany, Italy, and England. Value Health. 2021;24(7):930-938.
5 Essebag V, Verma A, Healey JS, et al. Clinically
Significant Pocket Hematoma Increases Long-Term Risk of Device
Infection: BRUISE CONTROL INFECTION Study. J Am Coll Cardiol
2016;67:1300-8.
6 Huntingdon Life Sciences Study TR-2013-001.
7 Sinclair Labs Study D13599.
8 Tarakji KG, et al. Antibacterial Envelope to
Prevent Cardiac Implantable Device Infection. NEJM. DOI:
10.1056/NEJMoa1901111
9 Wilkoff BL, et al. Cost-Effectiveness of an
Antibacterial Envelope for Cardiac Implantable Electronic Device
Infection Prevention in the US Healthcare System From the WRAP-IT
Trial. Circ Arrhythm Electrophysiol. 2020;13(10):e008503.
doi:10.1161/CIRCEP.120.008503.
10 Blomström-Lundqvist C, et al. European Heart
Rhythm Association (EHRA) international consensus document on how
to prevent, diagnose, and treat cardiac implantable electronic
device infections - endorsed by the Heart Rhythm Society (HRS), the
Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart
Rhythm Society (LAHRS), International Society for Cardiovascular
Infectious Diseases (ISCVID) and the European Society of Clinical
Microbiology and Infectious Diseases (ESCMID) in collaboration with
the European Association for Cardio-Thoracic Surgery (EACTS). EP
Europace. 2020
April;22(4) https://doi.org/10.1093/europace/euz246
11 Cleveland Clinic Unveils Top 10 Medical
Innovations for
2020. https://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations/Top-10-for-2020.
Downloaded July 10,2020.
12 Fast Company World Changing
Ideas Awards.
https://www.fastcompany.com/90619564/world-changing-ideas-awards-2021-health-finalists-and-honorable-mentions.
Downloaded July 13, 2021
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