Results of Independent Study of TYRX(TM) Absorbable Antibacterial Envelope
Additionally at Heart Rhythm 2015, researchers at Vanderbilt University Medical Center independently reported that the TYRX(TM) Absorbable Antibacterial Envelope was associated with a very low incidence of CIED-related infection in a high-risk population, comparable to that seen with the original non-absorbable TYRX Antibacterial Envelope.
"Our study is the first-of-its-kind, comparing the incidence of major cardiac device-related infection in high-risk patients who, during implantation, received either the TYRX Absorbable Envelope or the non-absorbable Envelope, with a control group of patients who did not receive a TYRX envelope," said Christopher R. Ellis, M.D., FHRS, FACC, principal investigator of the study and assistant professor of medicine at Vanderbilt University Medical Center. "After a minimum of three months, results showed only one reported infection in the 488 patients who received either the original or newer, absorbable TYRX Envelope, compared with 20 infections in the control group of 638 patients. Additionally, it was encouraging to find no difference in infection rates between the original TYRX Envelope and the newer, fully absorbable version."
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About CIED Infections
CIED infections occur in 1-7 percent6 of all CIED patients and about 3 percent of high-risk patients. High-risk patients include those patients with diabetes, with a previous history of infection, having a revision or upgrade procedure, or with renal failure or congestive heart failure. Most CIED site infections occur within the first three months. However, bacteria introduced during the implant can lay dormant in the subcutaneous pocket that houses the device under the skin and cause a delayed infection six months or more after implantation.
About the TYRX Antibacterial Envelope
The TYRX Antibacterial Envelope is a mesh envelope that holds an implantable cardiac device and is designed to stabilize the device after implantation while releasing two antimicrobial agents, minocycline and rifampin, over a minimum of seven days to help reduce surgical-site infections.
The TYRX Absorbable Antibacterial Envelope is fully absorbed by the body approximately nine weeks after implantation. Both TYRX Envelopes are FDA-cleared and have received CE Mark and are available in the United States and Europe.
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 that deliver clinical and economic value to healthcare consumers and providers around the world.
