Medtronic has announced the first patient enrolment in the WRAP-IT 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 at risk of infection.
The global clinical trial also will assess healthcare costs related to treatment of major infections in cardiac implantable electronic device patients. The first patient implant was performed by Edward J Schloss, director of electrophysiology at The Christ Hospital in Cincinnati, USA.
The Tyrx envelope is a mesh envelope that holds an implantable cardiac device and is designed to stabilise 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. Tyrx was cleared by the Food and Drug Administration in May 2013 and received CE mark in September 2014.
“This large-scale 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, 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. “It is important that we continue to find new ways to help reduce infections in patients with implantable cardiac devices, especially for those patients who are having repeat procedures.”
The rate of major infection in cardiac implantable electronic device 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% of all cardiac implantable electronic device patients), the potential for driving even lower rates of infection and lower healthcare costs with Tyrx are supported by US Centers for Medicare & Medicaid Services, which estimates the average cost of a cardiac implantable electronic device infection in the USA at US$72,485.
The trial will enrol approximately 7,000 patients at 225 sites worldwide. The trial will include patients who are recommended for a new cardiac resynchronisation 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, cardiac resynchronisation therapy pacemaker (CRT-P) device, implantable cardioverter-defibrillator or CRT-D device.
“Even though the risk of major infection is low for patients receiving implantable cardiac electronic devices, the Tyrx envelope offers an added layer of protection for patients at increased risk of infection,” said Marshall Stanton, vice president and general manager of the tachycardia business at Medtronic. “The Tyrx envelope is designed to be a simple, but cost-effective solution to help keep patients safer from major post-procedure infections and mechanical complications.”
The trial also will prospectively evaluate the performance of Medtronic lead monitoring algorithms such as Lead Integrity Alert and Lead Noise Alert software, to identify lead system issues in defibrillator patients.