First U.S. Implant Announced for Medtronic Evera MRI in Pivotal Clinical Trial
May 6, 2014 — Medtronic announced the first U.S. implant of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system, following U.S. Food and Drug Administration (FDA) approval for its investigational device exemption (IDE) application and pivotal clinical trial protocol.
Evera MRI is the first ICD system to be evaluated in the United States that allows for magnetic resonance imaging (MRI) scans positioned on any region of the body. The first device was successfully implanted at Marquette General Hospital in Marquette, Mich., by Mark Cowan, M.D., as part of the Medtronic randomized, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centers. The Evera MRI ICD system is currently available only for investigational use in the United States.
It is estimated that that as many as 63 percent of ICD patients will need an MRI within 10 years of receiving a device. Because no ICD system has yet been approved for MR-conditional use in the U.S., patients with devices have been contraindicated from receiving MRI scans; this is because of the potential interactions between the MRI, ICD function and patient safety.
“ICD patients in the U.S. are frequently denied access to MRI, and results from this clinical trial may give us the evidence needed to make MRI standard,” said Michael R. Gold, M.D., Ph.D., Michael E. Assay professor of medicine and director of cardiology at the Medical University of South Carolina, and principal investigator in the study. “We are optimistic about the possibilities that may be ahead for ICD patients, many of whom will need MRI scans during their lifetimes. Adding an ICD that would allow patients to have full-body access to MRI would be a significant breakthrough for this patient population.”
Evera MRI is designed to better fit inside the body, with a contoured shape and thin, smooth edges that increase patient comfort by reducing skin pressure by 30 percent. It is designed to maintain the same industry-leading battery longevity (up to 11 years) compared to previous devices. In addition, patients in the study implanted with Evera MRI will receive the Sprint Quattro Secure family of ICD leads, which has 10 years of proven performance with active monitoring and is designed to be safe in an MRI environment.
Evera MRI includes SmartShock 2.0, an exclusive shock reduction algorithm that is designed to enable the device to better differentiate between dangerous and harmless heart rhythms. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology has shown to help eliminate these inappropriate shocks, and delivers a 98 percent inappropriate shock-free rate at one year. Also included is OptiVol 2.0 fluid status monitoring and complete diagnostics, which is designed to identify patients at risk of worsening heart failure and atrial fibrillation.
For more information: www.medtronic.com