DUBLIN - May 6, 2015 - Medtronic plc (NYSE: MDT) today announced its schedule of notable clinical studies that will be presented at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions in Boston, including two late-breaking clinical trials featuring the Evera MRI® SureScan® implantable cardioverter-defibrillator (ICD) System and Micra® Transcatheter Pacing System (TPS).
Results from the Medtronic Evera MRI Clinical Trial - the world's first randomized clinical study to evaluate the safety and efficacy of an ICD that allows for full-body magnetic resonance imaging (MRI) scans - will be presented at the annual meeting's late-breaking clinical trials sessions on Thursday, May 14, 2015. Currently, patients with ICDs are contraindicated by the U.S. Food and Drug Administration (FDA) from receiving MRI scans because of potential interactions between the MRI and device function. The Evera MRI ICD System is currently investigational in the U.S.
The initial results of the Micra TPS Global Clinical Trial will kick-off Friday's late-breaking clinical trials session. The world's smallest pacemaker, Micra TPS is delivered with minimally invasive techniques through a catheter, and implanted directly into the heart. Micra TPS received CE (Conformité Européenne) Mark in April 2015.
In addition, HRS 2015 will include presentations evaluating Medtronic's quadripolar cardiac resynchronization therapy (CRT) system in heart failure patients using the Attain® Performa® quadripolar left ventricular leads, and results from the landmark Citadel/Centurion Clinical Study, which is investigating the effect of the Medtronic TYRX® Antibacterial Envelope on cardiac device infections and mechanical complications in high-risk patients.
"Heart Rhythm 2015 will feature significant clinical evidence from a number of Medtronic's cardiac rhythm and heart failure therapies," said John Liddicoat, M.D., president of the Cardiac Rhythm and Heart Failure division, and senior vice president of Medtronic. "This strong representation of data reinforces our commitment to collaborating with physicians to develop evidence that demonstrates the clinical and economic value of our innovations that meaningfully improve the care of patients."
A schedule of key presentations includes (all times are U.S. Eastern Daylight Time):
Thursday, May 14
- 2:30 p.m.: RF Heating of Micra: Can Patients with the Transcatheter Pacemaker Safely Undergo MRI? (Micra TPS, Room 205A)
- 2:45 p.m.: Is the Micra Intracardiac Pacemaker Suitable for All Adult Sizes and Ages? (Micra TPS, Room 205A)
- 2:45 p.m.: The Evera MRI Study (Evera MRI ICD Late-Breaking Clinical Trials I, Ballroom West)
Friday, May 15
- 8 a.m.: Performance of a Miniaturized Transcatheter Pacing System: First-In-Human Experience (Micra TPS Late-Breaking Clinical Trials II, Ballroom West)
- 9:30 a.m.: Serial Post-Implant Left Ventricular Vector Selection and Device Longevity (Attain Performa system, EPicenter, Exhibit Hall)
- 1:45 p.m.: Efficacy of a Bioabsorbable Antibacterial Envelope to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients (TYRX envelope, Room 210b)
- 2:30 p.m.: Citadel/Centurion Study Results (TYRX envelope, Room 205A)
Saturday, May 16
- 9:30 a.m.: Effectiveness of Steroid-Eluting Electrodes on Quadripolar Left Ventricular (LV) Leads - Results from a Large Worldwide Clinical Trial (Attain Performa system, Grand Ballroom Foyer, Level 3)
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.