Medtronic initiates patient enrollment for WRAP Infection clinical trial

Medtronic Inc. announced that it has begun enrollment for the WRAP Infection clinical trial, assessing the benefits of an absorbable antibacterial envelope for reducing incidence of major infections among patients with cardiac implantable electronic devices.

According to a press release, the TYRX absorbable antibacterial envelope is constructed of a mesh that holds the cardiac device in order to stabilize it following implantation. The envelope also releases antimicrobial agents inocycline and rifampin over 7 days or longer, and becomes fully absorbed by the body approximately 9 weeks after implantation. The FDA cleared the device for marketing in May 2013.

The trial will include approximately 7,000 patients collected from 225 sites worldwide. All participants will have been recommended for new treatment with a cardiac resynchronization therapy with defibrillation (CRT-D) or replacement, revision or upgrade of an existing implantable pulse generator, cardiac resynchronization therapy pacemaker, implantable cardioverter-defibrillator or CRT-D, according to the release.

Bruce Wilkoff

“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,” principal investigator Bruce Wilkoff, MD, director of cardiac pacing and tachyarrhythmia devices at the Cleveland Clinic and Cardiology Today Editorial Board member, said in the release. “It’s 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.”

Disclosure: Wilkoff is a paid consultant and serves on advisory boards for Medtronic, and also receives royalty payments from the company.