News | January 22, 2015

Medtronic Announces First Patient Enrollment in the WRAP Infection Clinical Trial

Will evaluate antibacterial envelope in cardiac implantable electronic device patients at risk for major infections

Clinical trial/study, EP Lab, WRAP Infection Clinical Trial

Image courtesy of TYRX

January 22, 2015 — Medtronic Inc. announced the first patient enrollment in the WRAP Infection clinical trial, which will evaluate the effectiveness of the TYRX Absorbable Antibacterial Envelope in reducing major infections in patients with cardiac implantable electronic devices (CIEDs) at risk for infection. The global clinical trial also will assess healthcare costs related to treatment of major infections in CIED patients. The first patient implant was performed by Edward J. Schloss, M.D., director of electrophysiology at The Christ Hospital in Cincinnati.

The Absorbable Antibacterial Envelope is a mesh envelope that holds an implantable cardiac device and is designed to stabilize the device after implantation while releasing antimicrobial agents, minocycline and rifampin over a minimum of seven days. The envelope is fully absorbed by the body approximately nine weeks after implantation. The Absorbable Antibacterial Envelope was cleared by the U.S. Food and Drug Administration (FDA) in May 2013 and received a CE Mark in September 2014.

"This trial is the first of its kind to evaluate an antibacterial envelope in cardiac device patients who are at risk for infections," said Bruce Wilkoff, M.D., director of Cardiac Pacing and Tachyarrhythmia Devices at the Cleveland Clinic, principal investigator in the trial and a paid consultant for Medtronic who serves on several Medtronic advisory boards and also receives royalty payments from Medtronic for technology he developed.  

The rate of major infection in CIED patients at 12 months following a procedure, and the consequent healthcare costs, will be compared between patients receiving a TYRX Absorbable Antibacterial Envelope at implantation and those not receiving the envelope. While infection rates remain relatively low (less than 3 percent of all CIED patients), the potential for driving even lower rates of infection and lower healthcare costs with TYRX are supported by U.S. Centers for Medicare & Medicaid Services, which estimates the average cost of a CIED infection in the United States at $72,485.

The trial will enroll approximately 7,000 patients at 225 sites worldwide. The trial will include patients who are recommended for a new cardiac resynchronization therapy with defibrillation (CRT-D) device, and patients who are recommended for a replacement, system revision or generator upgrade of an existing implantable pulse generator (IPG), cardiac resynchronization therapy pacemaker (CRT-P) device, implantable cardioverter-defibrillator (ICD) or CRT-D device.

The trial also will evaluate the performance of Medtronic lead monitoring algorithms - such as Lead Integrity Alert (LIA) and Lead Noise Alert (LNA) software - to identify lead system issues in defibrillator patients.

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