Medtronic’s Evera MRI SureScan ICD system gets Health Canada approval

22 December 2015 (Last Updated December 22nd, 2015 18:30)

Medtronic Canada has received approval from Health Canada for its implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans.

Evera

Medtronic Canada has received approval from Health Canada for its implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans.

The Evera MRI SureScan ICD system has been granted approval for MRI scans on any part of the body without positioning restrictions.

The company noted that the system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MRI conditional.

The Evera MRI ICD system is comprised of hardware and software design enhancements from previous generation devices, which enable it to safely undergo full-body MRIs.

It is paired with the Sprint Quattro Secure MRI SureScan DF4 leads, which provides active monitoring and tested for safe use in an MRI environment.

The approval was granted for the Evera MRI ICD system based on safety and efficacy data of the multi-centre, prospective, randomised and controlled Evera MRI clinical trial, which enrolled 275 patients at 42 centres across the globe.

The data showed that the Evera MRI ICD system is safe and effective when used as directed, while the full body MRI scans did not affect its ability to deliver life-saving therapy, said the firm.

"Medtronic is committed to ongoing innovation to address the clinical needs of physicians and patients."

Medtronic Canada president Neil Fraser said: "The Evera MRI ICD system underwent comprehensive computer modelling of more than 2.3 million clinical scenarios and this information, combined with the safety data from the clinical trial, has resulted in this important regulatory license.

"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."

Each year, about 45,000 Canadians die of sudden cardiac arrest (SCA), according to the Heart and Stroke Foundation.

The ICD system can be used to treat SCA, a sudden, abrupt loss of heart function, which can result in death if not treated within minutes with an electrical cardioverter shock.


Image: MRI Conditional Implantable Cardioverter Defibrillator. Photo: courtesy of Marketwired L.P / Medtronic Canada.