Medtronic starts shipping MRI-safe pacemaker in US

17 Feb 2011

Medtronic, Inc. has announced the immediate availability in the US of its Revo MRI SureScan MRI-safe pacemaker, following FDA approval.

This is the first MRI-safe system in the US. However, Medtronic's EnRhythm MRI SureScan pacemaker has been available in Europe since 2008. The company bought patents for making medical devices safe for use with MRI scanners from Biophan Technologies in 2007.

The strong magnetic fields in MRI scanners can affect pacemakers and injure the patient. Each year, an estimated 200,000 pacemaker patients in the United States have to forgo MRI scans.

“The new Revo MRI pacemaker is a major technological breakthrough for patients who need access to MRI,” said Dr J Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn. “Providing pacemaker patients with access to MRI allows detection and treatment of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopaedic conditions.”

“For the first time, patients will have access to a state-of-the-art pacemaker that is designed to work safely and effectively in an MRI environment,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “This milestone underscores Medtronic’s ongoing commitment to develop pacemaker technology that provides meaningful differences in patients’ lives.”

Prior to the introduction of Revo MRI, pacemaker patients could face serious complications if they were exposed to the powerful magnetic fields generated by MRI machines, which can be as much as 30,000 times more powerful than the Earth’s magnetic field.

Complications to exposure could include interference with pacemaker operation, damage to system components, or a change in pacing capture threshold, which is the minimum amount of current required to evoke a cardiac contraction.

The Revo MRI pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, since MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment.

When programmed into SureScan mode prior to an MRI scan, the Revo MRI pacemaker is designed to be safe for the MRI environment when used per the specified MR 'Conditions for Use'. Revo MRI is considered MR-Conditional, a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings.