FDA OK’s Medtronic Pacemakers for Full-Body MRI Scans

Medtronic, Inc. has announced the U.S. FDA approval of its Medtronic SureScan® pacing systems that are compatible with use of MRI scanning on any region of the body. Patients implanted with the Advisa DR MRI® or Revo MRI® SureScan pacing systems now can have MRI scans without positioning restrictions, including the chest area, which previously had been restricted.

Background

Until the availability of Medtronic’s SureScan pacemakers, U.S. patients had been contraindicated from receiving MRI scans due to potential interactions between the MRI and device function. According to published literature, up to 75 percent of patients worldwide with implanted cardiac devices are estimated to need an MRI scan during the lifetime of their devices.[1]

The recent approval was made following the FDA review of computer modeling and clinical data confirming that MRI chest-positioned scans are safe for patients. The first MR-Conditional pacemaker available in the U.S., the Medtronic Revo MRI, was FDA approved in February 2011, and the second-generation Advisa MRI was approved by the FDA in January 2013.

Company comments

“This approval allows for a more streamlined MRI scanning process and makes scanning the chest easier and more accessible for patients with pacemakers,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need.”

Reference: [1] Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328.

Source: Medtronic, Inc.

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