As the diagnostic capability of MRI continues to advance, and as the availability of MRI machines increases worldwide, so should the availability of implantable devices that are MRI safe. This advance is urgently needed says one executive.
While magnetic resonance imaging (MRI) is already well established as a premiere non-invasive imaging technology, patients with implantable pacemakers, implantable cardiac devices, neurostimulators and other medical devices are often denied the evaluation their medical situation urgently requires.
Why? The simple fact is that device safety is still an issue: People with implantable devices cannot undergo MRI.
In its March 29 issue, The New England Journal of Medicine published a study focused on the function and effectiveness of magnetic resonance imaging (MRI) in the detection of breast cancer. MRIs use magnetic fields to highlight and differentiate between normal and abnormal tissue. In nearly 1,000 women diagnosed with breast cancer in one breast, an MRI scan was able to detect breast cancer in the other breast in 3 percent (30 out of 969) women. The presence of these abnormal tissues was missed by both mammography and clinical examination
Missing out on a critically important diagnostic tool?
The NEJM study demonstrates the unique sensitivity of MRI as a diagnostic tool. Unlike mammography, MRI has the additional advantages of not exposing the patient to harmful radiation. It is especially unfortunate, therefore, that millions people with implantable medical devices in the United States alone, and millions more globally, cannot undergo MRI scans safely. For one, patients with breast cancer who also have implanted devices can not be exposed to MRI for the important diagnostic screening that could affect their treatment,? says Michael Weiner, CEO of Biophan Technologies, a public biotech company focused on making implantable devices safe for use with MRI imaging. These implantable devices include pacemakers and defibrillators used to treat heart disease as well as neurostimulators used to treat epilepsy and Parkinson’s disease.
Where the danger lies?
Implanted leads, which are wire-like devices, as well as other metallic devices, act as antennas and absorb energy from the MRI machine. This can cause the implanted device to heat up as well as generate voltages that can cause potentially fatal arrhythmias (irregular heart beat). Until these safety issues are resolved, these devices will continue to be contraindicated for use with MRI.
Creating the technology that will help make implantable devices safe for MRI is more critical than ever, says Mr. Weiner. In addition to denying breast cancer and many other patients access to sensitive MRI exams, it is likely that hundreds of people receive scans despite the presence of a metallic implant, placing them at risk of serious injury, even death. As the diagnostic capability of MRI continues to advance, and as the availability of MRI machines increases worldwide, so should the availability of implantable devices that are MRI safe. This advance is urgently needed,? adds Weiner.
Bridging the disconnect?
Biophan Technologies has been able to successfully enhance public awareness of the technological ?disconnect? between medical devices and MRI safety, and has contributed to improved methods of measuring heating and induced voltages in many commonly used medical devices. The patented technologies developed by Biophan can be built into leads and devices to reduce heating and induced voltages to safe levels, and by so doing ensure the safety of patients with these medical devices when undergoing MRI. Recognizing that different devices have varying design requirements, Biophan has in fact developed a wide range of innovative solutions for the various types of implants.
Avoiding more invasive types of diagnostics?
The known presence of an implant often forces patients to undergo more invasive, less effective, and risky procedures, that can include exposure to toxic contrast media or ionizing radiation, both of which can have serious side effects. Eliminating these hazards and ensuring that all patients have access to the best technology will be great news for patients and for the healthcare industry as a whole,? says Weiner.