Press Release

Medtronic Launches TYRX™ Envelope in India: An Innovative Solution to Stabilize and Help Reduce Infections Associated With Cardiac Implants


Business Wire India

Significantly Reduces the Risk of Major Infection by 40% in Patients with Cardiac Implantable Devices, and Reduces Pocket Infections by 61% [i]
 
India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc (NYSE: MDT), today announced the launch of the TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) – an absorbable, single-use, antibacterial envelope designed to stabilize a cardiac implantable electronic device (CIED) or implanted neurostimulator while releasing antimicrobial agents over a minimum of seven days.[ii] Constructed from a multifilament, knitted absorbable mesh, the TYRX Envelope holds the CIED device and is fully absorbed by the body approximately nine weeks after implantation.[iii] It can be used with any implantable defibrillator, pacemaker, or neurostimulator.
 
Annually in India, 50,000 people with heart conditions receive a CIED, such as a pacemaker or implantable cardioverter defibrillator (ICD), to help manage abnormal heart rhythms.[iv] As with any surgical procedure, there is risk for infection due to bacteria being introduced at the time of implantation. Current standard of care for CIED infection treatment includes complete system removal/replacement and prolonged antibiotic therapy.
 
“We strive to offer products and services of the highest quality that deliver clinical and economic value to patients and physicians. TYRX is one such value-based offering aimed at lowering infection risk and reducing readmission rates with the long-term goal of creating better outcomes,” said Abhishek Bhargava, director, Cardiac Rhythm Management, Cardiac Ablation & Diagnostics at Medtronic India. “Medtronic’s vision remains anchored on introducing innovations that continue to alleviate pain, restore health and extend life.”
 
CIED infections occur in 1-4%[v] of all CIED patients and are associated with substantially increased morbidity, mortality, and cost.[vi] Results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT)1 demonstrated the TYRX Envelope reduced the risk of major infection by 40% in patients with CIEDs, and reduced pocket infections by 61%, when used as an adjunctive therapy in addition to standard-of-care infection prevention strategies for patients at higher risk of infection. Further, it did not increase the risk of procedure-related or system-related complications through 12 months. The study enrolled approximately 7,000 patients, from 181 centers in 25 countries in Asia, Europe, North America, and South America.
 
The study population included patients receiving an initial 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.
 
The TYRX Envelope was cleared by the FDA in 2013 and received CE Mark in 2014.
 
In 2019, the European Heart Rhythm Association (EHRA) issued an international consensus document on how to prevent, diagnose and treat CIED infections. The TYRX Envelope is recommended for the WRAP-IT study population and patients with other high-risk factors as outlined in the document.[vii]

References
 


[i] Tarakji KG, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. NEJM. DOI: 10.1056/NEJMoa1901111
[ii] Huntingdon Life Sciences Study TR-2013-001.
[iii] Sinclair Labs Study D13599.
[iv] Eucomed data
[v] Data on file for aggregated infection rate.
[vi] Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med 2011; 171:1821–1828.
[vii] 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




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