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Medtronic’s MRI-Compatible ICD System Receives FDA Approval

The first implantable cardioverter defibrillator system for use with an MRI scan has been approved by the FDA: the Evera MRI SureScan ICD System from Medtronic. The company hopes the system, which will allow clinicians to conduct important imaging studies of all anatomical locations, will give Medtronic a competitive edge over other ICDs, and will lead to market share gains in the US.

Medtronic PLC received PMA in September for the first implantable cardioverter defibrillator (ICD) system for use with an MRI scan. The patient population that will benefit from the Evera MRI SureScan ICD System is already indicated for an ICD: those at risk for sudden cardiac arrest (SCA) or ventricular arrhythmias. “ICDs have been saving lives for more than 30 years by delivering a lifesaving shock or painless pacing to stop life-threatening fast or irregular heartbeats,” says Marshall Stanton, MD, vice president and general manager of the tachycardia business at Medtronic. “However, prior to this approval, FDA had contraindicated ICD patients from receiving MRI scans because of potential interactions between the MRI magnet and implanted device.” Further, the Centers for Medicare and Medicare Services (CMS) “does not reimburse MRI scans done on patients who have ICDs or pacemakers that are not labeled for use in MRI scanners,” Stanton notes.

The added benefit of the Evera MRI ICD over non-MRI ICDs is that patients can safely undergo an MRI scan – considered the gold standard for soft-tissue imaging – which may be ordered by a physician to help diagnose another condition

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