News | May 21, 2015

Tyrx Antibacterial Envelope Reduces Cardiac Device Infection Rates at 12 Months

Long-term Citadel/Centurion clinical trial findings and independent data presented at Heart Rhythm 2015

Medtronic, Tyrx Antibacterial Envelope, Heart Rhythm 2015, CIED infections

May 21, 2015 — Medtronic plc announced that its Tyrx Antibacterial Envelope reduces major cardiac device site infections by 80 percent up to 12 months after implantation. These data were presented at Heart Rhythm 2015, the Heart Rhythm Society’s 36th annual scientific sessions in Boston.

The Citadel/Centurion clinical trials are the first prospective, multicenter studies to evaluate the impact of the Tyrx Antibacterial Envelope on cardiac implantable electronic device (CIED) major infections and mechanical complication rates following implantation in high-risk patients. The results show a low rate of surgical site infection at 12 months (0.44 percent) in the 1,129 patients who received the envelope compared with a control group of similar patients reported in previously published literature who did not receive an envelope (2.2 percent; p=0.0023).

CIED infections are associated with substantial morbidity, mortality and cost, and are increasing in frequency. The average cost of a CIED infection in the United States is estimated at $54,926.

“Clinical studies show that the use of the Tyrx Envelope is associated with a significant reduction in implant-related cardiac device site infections,” said Charles A. Henrikson, M.D., MPH, FHRS, chief of electrophysiology at Oregon Health & Science University in Portland. “These new findings reveal that the Tyrx Envelope decreases the rate of infections that can occur within the first year after implantation. This is very good news for patients, especially given the associated mortality and costs tied to CIED infection.”

The Citadel/Centurion clinical trials enrolled 1,129 patients at 55 centers in the United States. Study participants were at high risk for infection because they were undergoing a CIED replacement procedure with either an implantable cardioverter-defibrillator (ICD) (Citadel) or a cardiac resynchronization therapy (CRT) device (Centurion). Primary endpoints were major CIED infection (involving any site other than skin or subcutaneous tissue of the incision, or endocarditis) and CIED mechanical complication over 12 months of follow-up. The frequency of CIED mechanical complications in patients implanted with the TYRX Envelope was low.

Additionally at Heart Rhythm 2015, researchers at Vanderbilt University Medical Center independently reported that the Tyrx 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.”

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 U.S. Food and Drug Administration (FDA)-cleared and have received CE Mark and are available in the United States and Europe.

For more information:

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Overlay Init