Image

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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."

"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.