Medtronic has reported the first US implant of the Evera MRI SureScan implantable cardioverter-defibrillator (ICD) system, following Food and Drug Administration (FDA) approval for its investigational device exemption (IDE) application and pivotal clinical trial protocol.
Evera MRI is claimed to be the first ICD system to be evaluated in the US that allows for magnetic resonance imaging (MRI) scans positioned on any region of the body.
Dr Mark Cowan has successfully implanted the first device at Marquette General Hospital in Marquette, Michigan, as part of the Medtronic randomised, global pivotal clinical trial that will enroll up to 275 patients at approximately 45 centres.
It is estimated that that as many as 63% of ICD patients will need an MRI within ten years of receiving a device. Compared with other ICDs available, the Evera MRI system gives patients the most unrestricted access to MRI scans.
The Medical University of South Carolina professor Michael E Assay and principal investigator in the study Dr Michael Gold said ICD patients in the US are frequently denied access to MRI, and results from this clinical trial may provide evidence needed to make MRI standard.
"We are optimistic about the possibilities that may be ahead for ICD patients, many of whom will need MRI scans during their lifetimes," Dr Gold said.
"Adding an ICD that would allow patients to have full-body access to MRI would be a significant breakthrough for this patient population."
Featuring a contoured shape with thin, smooth edges, the new Evera MRI ICD system better fits inside the body and increases patient comfort by reducing skin pressure by 30%. Compared with previous devices, the new system has battery longevity of up to 11 years.
Medtronic's Evera MRI ICD system is paired with the Sprint Quattro secure family of ICD leads. The device incorporates SmartShock 2.0, OptiVol 2.0 fluid status monitoring and complete diagnostics.
SmartShock 2.0 is a shock reduction algorithm, which enables the ICD to better differentiate between dangerous and harmless heart rhythms. It helps to eliminate the inappropriate shocks, and delivers a 98% inappropriate shock free rate at one year.
In addition, OptiVol 2.0 fluid status monitoring and complete diagnostics help to identify patients at risk of worsening heart failure and atrial fibrillation.
Medtronic vice-president and general manager of the tachycardia business Dr Marshall Stanton said the company's goal with the Evera MRI system is to give patients the most unrestricted access to MRI scans, and allow them to get the diagnostic answers they need.
"Medtronic has been a leader in developing implantable devices that are safe for the MRI environment, and we believe ICDs will be no exception in the near future," Dr Stanton said.
Image: Medtronic's world headquarters in Minneapolis, US. Photo: courtesy of Medtronic Inc.