Prospective Studies of Patients at High Risk for Cardiac Device Infections
MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Apr 2, 2012-- TYRX(R), Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with cardiovascular implantable electronic devices (CIEDs), announced today that the 1000th patient has been enrolled into the CITADEL & CENTURION clinical studies evaluating the company's AIGISRx Antibacterial Envelope.
CITADEL & CENTURION are prospective, multicenter clinical studies, designed to enroll 4300 subjects at over 50 U.S. study sites. The studies are evaluating the use of AIGISRx in patients who are at high risk for CIED infection 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 1) major ICD/CRT device-related infections and 2) ICD/CRT device-related mechanical complications. Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.
The AIGISRx Envelope is a mesh device that securely holds a pacemaker or ICD, creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotic agents rifampin and minocycline, which elute over a 7 to 10 day period to help reduce infections associated with CIED implantation.
"CIED infections present substantial challenges to patients and the physicians who care for them. CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers. These studies are important because they will generate useful clinical information on the use of AIGISRx in a wide variety of patients at high risk for CIED infection," stated Walter Paladino, MD, FACC, St. Elizabeth Hospital, Youngstown, Ohio.
TYRX Chief Medical Officer, Daniel Lerner, MD, commented that "CIED infections are associated with substantial morbidity, mortality, and cost, and are increasing in frequency. The risk of CIED infection is significantly increased in patients who receive a replacement device.
The CITADEL & CENTURION studies are large prospective studies that will provide useful data on the clinical performance of the AIGISRx in these patients." The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the U.S. and around the world (www.ClinicalTrials.gov) About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx(R) Antibacterial Envelope, designed to reduce surgical-site infections associated with Cardiovascular Implantable Electronic Devices (CIEDs). AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including "superbugs" or MRSA*. Following commercial release, the AIGISRx Envelope has been used in over 25,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2012 will receive an AIGISRx product during their procedure.
TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
For more information, please visit www.tyrx.com or www.heartdeviceinfection.com.
* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009; 32(7) 898-907.
CONTACT: TYRX, Inc.
Robert White, 732-246-8676 President and Chief Executive Officer info@TYRX.com KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY INDUSTRY KEYWORD: SURGERY HEALTH CARDIOLOGY CLINICAL TRIALS MEDICAL DEVICES PROFESSIONAL SERVICES INSURANCE SOURCE: TYRX, Inc.
Copyright Business Wire 2012 PUB: 04/02/2012 08:00 AM/DISC: 04/02/2012 08:00 AM http://www.businesswire.com/news/home/20120402005009/