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Friday, February 11, 2011

First Pacemaker which can work safely during MRI scanning approved by US FDA

First Pacemaker which can work safely during MRI scanning approved by US FDA.
The US FDA on approved a pacemaker specially designed for peoples who require frequent magnetic resonance imaging ( MRI ) scanning , with this pace maker a patient can be subjected to MRI examination. As almost 50% of the patients with pacemaker require MRI scanning one or the other time but are not advised for the same as MRI scanning could affect pacemaker itself.

Drawback with earlier pacemakers available was that the patients could not be subjected to MRI examinations as MRI magnetic resonance imaging apply heavy magnetic fields and radio frequency pulses which can disrupt the pacemaker, due to heavy magnetic fields wires may get heated and can result in to irregular impulses and stimulation's to heart muscles and even damage to heart tissue where it comes in direct contact.

The newly approved pacemaker is developed even to work under such conditions of heavy magnetic fields and radio frequencies. About half of all patients with pacemakers might require an MRI scaning in their life, but are not advised for MRI  because  MRI’s magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.

The name of this pacemaker is Revo MRI SureScan Pacing system, it is manufactured by Medtronic Inc. of Mounds View, Minn

The Revo MRI SureScan Pacing System consists of a function which is required to be turned on before a MRI scan so as to prepare patients for the MRI. The Revo pacemaker’s use too is limited to certain patients and also it is limited for certain body parts scanning. It requires certain MRI scanning parameters too for safe use during MRI scanning. The US FDA requires detailed training of cardiologists and radiologists which will be using Revo MRI SureScan Pacing as well.

US FDA approved Revo pacemaker after reviewing results from one clinical trial with 484 subjects out of them only 464 got pacemaker device implant successfully and were randomized for MRI scanning and it was observed that the out of 211 patients with implant subjected for MRI can did not experienced MRI-related complication which otherwise are seen with conventional pacemaker devices . other nonclinical research and earlier data from animal studies helped to confirm the clinical trial results.

Also see What is Post Market Study 

What is Magnetic resonance imaging MRI :
One or the other point in our life we have seen a image of one or the other bone in x ray film ,similarly MRI is the medical imaging technique wit which one can get images of soft tissues and organs like heart , liver , brain tissues, at different levels in side them , one can see the exact picture of inner tissue in organs as it is actually inside our body .

Magnetic resonance imaging (MRI), magnetic resonance tomography (MRT, nuclear magnetic resonance imaging (NMRI), Makes use of property of an atom to produce an magnetic fields when a strong magnetic field is applied then a radio frequency is applied over them to visualize the magnetic field of these atoms, in MRI certain atoms of our body tissue are excited and produce magnetic fields which is systematically detected and constructed or formed in to an image, these image can be viewed on computer screen or a copy can be taken on a film, similar principal is applied in visualization of chemical structure of a molecule the technique applied there is well known as nuclear magnetic resonance imaging NMR. Like CT scan MRI do not use ionizing radiation which are harmful to certain extent.

MRI image of knee

MRI can produce images with different contrast in tissue so that exact 3 D spatial arrangement of the tissue in our body can be viewed in an image.















Because of heavy magnetic fields, atoms in our body may get heated up therefore it is likely that body temperature may rise in an individual subjected to MRI for longer duration.

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