Medtronic has reported positive results from the WRAP-IT clinical trial.
The randomised, multi-centre study evaluated the company’s TYRX Absorbable Antibacterial Envelope in patients with cardiac implantable electronic devices (CIED).
TYRX is a mesh envelope designed to hold an implantable cardiac device or implantable neurostimulator. It stabilises the device after implantation, as well as releases antimicrobial agents, minocycline and rifampin over a minimum of seven days. The envelope is fully absorbed around nine weeks after implantation.
WRAP-IT was performed at 181 centres in 25 countries across North America, Europe, Asia and South America in a total of 6,983 patients. The envelope was successfully implanted in 99.7% of procedure attempts.
The trial met its primary endpoint, with TYRX envelope demonstrating a 40% decrease in the risk of major infection at 12 months, compared with standard-of-care pre-operative antibiotics.
Data showed that 0.7% of patients treated with the TYRX envelope had a major infection, in comparison with 1.2% of participants in the control group.
In addition, the envelope led to a 61% reduction in pocket infections.
The trial met its safety objective of no increase in the risk of procedure or system related complications through 12 months.
TYRX received US Food and Drug Administration (FDA) clearance in 2013 and the European CE-Mark in 2014.
Medtronic Cardiac Rhythm and Heart Failure division vice-president and chief medical officer Rob Kowal said: “These data provide strong evidence that the TYRX envelope can help prevent major infection without increasing complications.
“This is the largest CIED trial ever conducted globally, demonstrating Medtronic’s commitment to generating high-quality evidence supporting the use of our products and therapies to improve patient outcomes.”
The study’s findings have been presented at the American College of Cardiology’s 68th Annual Scientific Sessions and published in The New England Journal of Medicine .
CIEDs are commonly used to manage abnormal heart rhythms. Implanted through a surgical procedure, the devices are associated with risk for infection due to bacteria introduced during the implant. Statistics show that this type of infection occurs in 1%-4% of all CIED implant patients and result in increased risk of death.