The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the Evera MRI Clinical Trial, a multicenter, prospective, randomized, controlled clinical trial that enrolled 275 patients at 42 centers around the world. Presented during a late-breaking clinical trial session at Heart Rhythm 2015, the Heart Rhythm Society's 36th Annual Scientific Sessions, and published simultaneously in the Journal of the American College of Cardiology (JACC), these data demonstrated that the Evera MRI ICD system is safe and effective, and that full-body MRI scans did not affect its ability to deliver life-saving therapy.3
"The Evera MRI ICD system underwent comprehensive computer modeling of more than 2.3 million clinical scenarios and this information, combined with the safety data from the clinical trial, has resulted in this critical regulatory approval," said Marshall Stanton, M.D., vice president and general manager of the Tachycardia business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic. "As pioneers in the development of implantable cardiac devices that can be used in an MRI environment, Medtronic is committed to ongoing innovation to address the clinical needs of physicians and patients."
Ad Statistics
Times Displayed: 109208
Times Visited: 6638 MIT labs, experts in Multi-Vendor component level repair of: MRI Coils, RF amplifiers, Gradient Amplifiers Contrast Media Injectors. System repairs, sub-assembly repairs, component level repairs, refurbish/calibrate. info@mitlabsusa.com/+1 (305) 470-8013
About the Evera MRI ICD
The Evera MRI ICD is part of the Evera family of ICDs and includes the following key features and benefits:
A contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30 percent4
Industry-leading projected battery longevity (up to 11 years) compared with previous devices5-12
SmartShock(TM) 2.0, the Medtronic exclusive, industry-leading shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms13
OptiVol® 2.0 Fluid Status Monitoring and complete diagnostics, which is designed to identify patients at risk of worsening heart failure and atrial fibrillation
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.
Multimedia Release
A multimedia version of this release, with links to graphics and additional background information can be found at: http://bit.ly/1KLJcnW
