Medtronic has announced the first US implant of the Evera MRI SureScan implantable cardioverter defibrillator (ICD) System, following US Food and Drug Administration (FDA) approval for its investigational device exemption application and pivotal clinical trial protocol.
According to a company release, Evera MRI is the first ICD system to be evaluated in the USA 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, USA by Mark Cowan as part of the Medtronic randomised, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centres. 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% 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 USA, 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 USA are frequently denied access to MRI, and results from this clinical trial may give us the evidence needed to make MRI standard,” says Michael R Gold, director of cardiology at the Medical University of South Carolina, USA, 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.”
The company release states that the 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% and 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.