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Medtronic implantable devices approved by FDA for use in 3-T MRI systems
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Medtronic announced that its implantable cardiac rhythm and HF devices have been approved by the FDA to be scanned in 3-T MRI systems.
The devices (SureScan family of products) are the first to be approved for use with 3-T MRI in the United States and were previously approved to be scanned in 1.5-T MRI systems, according to a press release issued by the company.
Patients with any SureScan device can now get an MRI scan on any part of the body, Medtronic stated in the release.
The approval applies to the following devices: Advisa MRI pacemaker; Micra transcatheter pacemaker; Amplia MRI and Complia MRI cardiac resynchronization therapy defibrillators; Evera MRI, Visia AF MRI DF-1 and Visia AF MRI DF-4 implantable cardioverter defibrillators; Reveal LINQ insertable cardiac monitor; and SureScan pacing, defibrillation and left-heart leads.
The company stated in the release that 12% to 16% of patients with implantable cardiac devices have a need for MRI each year, but less than 1% of them receive one because of contraindications with the device or leads.
“The potential interaction between cardiac devices and MRIs has been a long-running concern for patients and physicians,” Marc T. Silver, MD, FACC, cardiologist at WakeMed Heart and Vascular Physicians, Raleigh, North Carolina, said in the release. “Fortunately, advances in MR-conditional cardiac device technology give patients more access to this important diagnostic tool.”
Disclosure : Silver reports consulting and speaking for Medtronic.