TYRX begins enrollment in CITADEL study for Aigisrx anti-bacterial agent

Mar 24 2010

TYRX, Inc., a leader in the commercialization of implantable medical devices designed to help reduce infection, announced today that it has begun enrollment in CITADEL, the second of two large scale, prospective, multicenter studies.

CITADEL will enroll 2,300 patients at over 50 clinical study sites across the U.S. Each patient is currently implanted with either a pacemaker, implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device which will be replaced with an ICD accompanied by AIGISRx. This patient population will be compared to a group of published control patients who have also undergone a pacemaker, ICD or CRT device replacement with an ICD without AIGISRx. The primary endpoints will be 1) major ICD device-related infection and 2) ICD device mechanical complication. Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.

The first study, known as CENTURION, enrolled its first patient in January of this year. CENTURION is a prospective, multicenter, monitored registry that will enroll 2,000 patients at over 50 clinical study sites across the U.S. Each patient is currently implanted with either a pacemaker, ICD or CRT device which will be replaced with a CRT device accompanied by AIGISRx. This patient population will be compared to 2000 case-matched controls that have also undergone a pacemaker, ICD or CRT device replacement with a CRT without AIGISRx. The primary endpoints will be 1) major CRT device-related infection and 2) CRT device mechanical complication. Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.

AIGISRx is an anti-bacterial mesh envelope developed to deliver anti-microbial agents that help provide protection against infections associated with implanted pacemakers and cardioverter defibrillators. AIGISRx also securely holds a pacemaker (PM) or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body.

Dr. Ibrahim Hanna, Director of Cardiac Electrophysiology at Cardiology PC and Princeton Baptist Medical Center, Birmingham, AL states, “Device implanters are keenly aware of the risk of pocket infections, especially in patients with underlying health conditions. To date our ability to impact this issue has been limited. We are excited about the prospect of testing a simple, intuitive, and potentially highly effective approach to the problem. The TYRX antibacterial envelope is placed around the device and leads and left in the pocket allowing a cocktail of antibiotics to elute over 7 days. We have enrolled our first patient in CITADEL and found the envelope very simple to use. It did not add any significant time or risk to the procedure and the whole process went very smoothly. Patients stand to benefit greatly from this innovative technology. ”

Dr. Dan Lerner, TYRX Chief Medical Officer notes, “CRM device infections are associated with substantial morbidity, mortality, and cost. Published data reveal the frequency of these infections is increasing faster than the rate of CRM device implants, indicating there is a need for more effective antimicrobial prophylaxis. CITADEL and CENTURION are large, multicenter, prospective studies that will provide important information on the clinical performance of AIGISRx in two groups at particularly high risk for infection – CRM device replacements with an ICD or a CRT.”

Dr. Lerner also commented, “Published data indicate the risk of CRM device infection is higher for ICDs compared to pacemakers, and for replacement procedures compared to initial implants. The CITADEL study will enroll 2,300 patients who have undergone CRM device replacements with a single- or dual-chamber ICD, and follow them prospectively for CRM device infection and mechanical complications during the 12 months following the procedure, to better understand the clinical performance of AIGISRx in this group at particularly high risk for CRMD infection.”