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Cardiac imaging news The US Food and Drug Administration (FDA) has recently approved the first MRI-compatible cardiac pacemaker. Revo MRI SureScan Pacing System produced by Medtronic Inc. is now ready for immediate shipping.

Heart pacemakers are devices that produce electric impulses to regulate heart beats. As the population ages, the use of pacemakers is growing, with approximately 5 million patients worldwide depending on implaned pacemakers or implantable cardioverter-defibrillators. At the same time, the use of MRI as a diagnostic tool is increasing. However, patients using these devices had to avoid undergoing MRI scans as the powerful magnetic fields generated during the imaging procedures (which can be as much as 30.000 times more powerful than the Earth's magnetic field), interfere with the pacemakers' function.

Medtronic estimates a number of  200,000 U.S. pacemaker patients each year that opt out of MRI scans, despite being a critical tool for diagnosing a wide range of diseases.

The Revo MRI SureScan Pacing System has a function that can be turned on before a scan to prepare these patients for the MRI machines.  This feature helps in limiting or even completely eleminating any potential MRI hazard.

'A major technological breakthrough for patients who need access to MRI,"  proudly comments J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville. 

"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 orthopedic conditions,' Gimbel added.

"FDA's approval of the Revo pacemaker represents an important step forward toward greater device innovation. Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI," concluded Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

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