TYRX, a provider of implantable cardiac devices, has enrolled 1000th patient for CITADEL and CENTURION clinical studies.
The multicenter, prospective studies, which enrolled 4300 US patients, are designed to assess the use of AIGISRx in patients who are at high risk for cardiovascular implantable electronic devices (CIED) infections.
TYRX said patients are suffering from infections because their current CIED is being replaced with either an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device, accompanied by the AIGISRx.
The primary endpoints for both studies are major ICD/CRT device-related infections and ICD/CRT device-related mechanical complications.
Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.
TYRX chief medical officer Daniel Lerner said the CITADEL and CENTURION studies are prospective studies that will provide useful data on the clinical performance of the AIGISRx in these patients.
The AIGISRx Envelope is a mesh device which holds a pacemaker or ICD, thus creating a stable environment surrounding the device and leads after surgical placement.
AIGISRx’s mesh is coated with antibiotic agents like rifampin and minocycline, which elute over a 7 to 10 day period to help reduce infections associated with CIED implantation.