News | October 29, 2010

Study Site Enrollment Completed for EP Device Antibacterial Envelope

October 29, 2010 – Site enrollment has been completed for the 50-site CITADEL and CENTURION clinical studies to evaluate the Tyrx AigisRx Antibacterial Envelope. The device is designed to help reduce surgical-site infections (SSIs) associated with cardiac implantable electronic devices (CIEDs).

The trials are both large, prospective, multicenter clinical studies, which together, will enroll 4,300 subjects at 50 clinical study sites across the United States. Patients enrolled in these studies have a pacemaker, implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device that will be replaced with an ICD or CRT device accompanied by AigisRx.

In the CITADEL study, prospectively enrolled patients receiving AigisRx will be compared to published controls who have undergone pacemaker, ICD or CRT device replacement with an ICD without AigisRx.

In the CENTURION study, prospectively enrolled patients will be compared to 2000 case-matched controls that have undergone pacemaker, ICD or CRT device replacement with a CRT without AigisRx.
The primary endpoints for both studies will be 1) major ICD/CRT device-related infections and 2) ICD/CRT device-related mechanical complications. Patients will be followed for 12 months, with predefined interim analyses at three and six months.

The AigisRx Envelope is an antibacterial mesh envelope designed to deliver antimicrobial agents which help provide protection against infections associated with implanted pacemakers and ICDs/CRTs. AigisRx also securely holds a pacemaker or ICD/CRT in order to create a stable environment when implanted in the body.

“Published data shows us that the risk of CIED infection is higher for ICDs/CRTs in comparison to pacemakers. Additionally, replacement procedures carry more infection risk compared to initial implants. The CITADEL and CENTURION studies will provide vital information on the clinical performance of AIGISRx in these particularly high risk groups for CIED infection,” said Scott Burkett, M.D., FACP, FACC, Burkett Heart Clinic, Monroe, La.

Tyrx commercializes innovative, implantable combination drug/device products focused on infection control, including the AigisRx Antibacterial Envelope and AigisRx Flat Sheet products. Their products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in cardiac implantable electronic device (CIED)-related endocarditis, including “superbugs” or MRSA.

For more information: www.tyrx.com

Related Content

Mexican Doctors Safely Reuse Donated Pacemakers After Sterilization

Mexican government reports conclude more than half of the population does not have access to social security or private insurance that covers a pacemaker implant, and 44 percent live in poverty. Recycling donated, explanted pacemakers offers a new option for these patients.

News | Pacemakers| November 10, 2017
Mexican doctors have safely reused donated pacemakers after sterilization, shows a study presented at the 30th Mexican...
Pacemakers and Other Cardiac Devices Can Help Solve Forensic Cases
News | Pacemakers| June 20, 2017
Pacemakers and other cardiac devices can help solve forensic cases, according to a study presented at the European...
Videos | Pacemakers| May 23, 2017
Vivek Reddy, M.D., director of cardiac arrhythmia services and professor of medicine, cardiology, Mount Sinai Hospita
micra leadless pacemaker
Feature | Pacemakers| May 16, 2017
May 16, 2017 - The preliminary results for the Medtronic Micra Transcatheter Pacing System (TPS) Post-Approval Regist
Videos | Pacemakers| May 16, 2017
This video, provided by Medtronic, demonstrates the implantation of Micra transcatheter pacing system (TPS).
closed loop stimulation, DDD-CLS, ACC17, SPAIN trial
Feature | Pacemakers| March 22, 2017
March 22, 2017 — Patients with recurrent fainting episodes (syncope) who received a pacemaker delivering a pacing pro
Micra leadless pacemaker, CMS, medicare reimbursement
News | Pacemakers| March 10, 2017
March, 10, 2017 - Medtronic announced that the U.S.
Medtronic, Micra TPS pacemaker, transcatheter pacing system, global clinical trial, one-year results, ESC 2016
News | Pacemakers| August 29, 2016
August 29, 2016 — Medtronic plc announced new long-term results from the Medtronic Micra Transcatheter Pacing System
Medtronic, Micra TPS pacemaker, Global Clinical Trial, Cardiostim 2016
News | Pacemakers| June 09, 2016
Medtronic plc announced new results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in...
Medtronic, Micra TPS, transcatheter pacing system, pacemaker, Jersey Shore University Medical Center, New Jersey first
News | Pacemakers| June 06, 2016
Jersey Shore University Medical Center, part of Meridian CardioVascular Network, is the first hospital in New Jersey to...
Overlay Init