US-based medical devices company Medtronic has announced results from its Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), which showed that TYRX Absorbable Antibacterial Envelope (TYRX envelope) reduced infections in patients with cardiac implantable electronic devices (CIEDs).
The WRAP-IT results demonstrated the TYRX envelope reduced the risk of major infection by 40%, and pocket infection by 61%, in patients with CIEDs compared to standard-of-care pre-operative antibiotics.
WRAP-IT is a randomized, prospective, multicenter, single-blinded, global, post-market, interventional clinical trial, which compared the incidence of major infections in patients whose CIED implantation included the TYRX envelope and patients whose procedure did not, with follow up to 12 months.
Medtronic said that the study was conducted in 181 centers in 25 countries in North America, Europe, Asia and South America, and included 776 implanters and a total of 6,983 patients participated in the trial with 3,495 randomized to receive the TYRX envelope and 3,488 randomized to the control group (without the envelope).
The company has designed the TYRX envelope as a mesh envelope holding an implantable cardiac device or implantable neurostimulator, to stabilize the device after implantation while releasing antimicrobial agents, minocycline and rifampin, over a minimum of seven days. The envelope is absorbed by the body within approximately nine weeks after implantation.
TYRX envelope showed that at 12 months, 1.2% of patients in the control group experienced a major infection, while only 0.7% of patients who received the TYRX envelope had a major infection (p=0.04). The trial also showed a 61% reduction in pocket infections with the envelope (p<0.01).
Medtronic has presented the trial results in a session conducted at the American College of Cardiology’s 68th Annual Scientific Sessions, and published the results in The New England Journal of Medicine. The TYRX Envelope was cleared by the FDA in 2013 and received CE Mark in 2014.
Medtronic cardiac rhythm and heart failure division chief medical officer and vice president 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.”
Medtronic claims that it offers a broad range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias, in collaboration with leading clinicians, researchers and scientists across the world.