Late-Breaking Clinical Trial Sessions Feature First Data on Evera MRI® ICD and Micra® TPS
DUBLIN - 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.
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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)
