Significantly reduces the risk of major infection by 40 per cent in patients with cardiac implantable devices
Medtronic announced the launch of the TYRX Absorbable Antibacterial Envelope (TYRX Envelope) – a single-use, antibacterial envelope designed to stabilise a cardiac implantable electronic device (CIED) or implanted neurostimulator while releasing antimicrobial agents over a minimum of seven days. 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. 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. As with any surgical procedure, there is a risk for infection due to bacteria being introduced at the time of implantation. The 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.”
Results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) demonstrated the TYRX Envelope reduced the risk of major infection by 40 per cent in patients with CIEDs, and reduced pocket infections by 61 per cent when used as 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 centres 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.