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.

For more information:,

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init