The tests, conducted in a 1.5 Tesla MRI machine, prevented most of the radio frequency (RF) energy emitted by the MRI machine from reaching the shielded samples. The RF energy from an MRI is known to be the cause of dangerously high tissue heating and other performance problems in electronic medical devices used in the body, such as implantable pacemakers, cardioverter-defibrillators, and neurostimulators and interventional devices such as guidewires and catheters. Because of these heating problems, the FDA in 1997 issued a contraindication for some of these devices.
Biophan said its shielding technology, which uses thin-film nanomagnetic and carbon composite coatings, could potentially be used with implanted biomedical devices to enable patients to safely undergo MRI exams. The initial tests were performed on coated wafers and coated metal rods. The next tests will be performed on coated pacemaker leads in a saline solution phantom, approximating the effects of a human body in an MRI coil.
The company said the test results could expand the market for its MRI-safe solutions beyond implanted pacemakers, including interventional surgical products used with MRI, such as guide wires, catheters and biopsy probes and interoperative imaging products such as intraluminal MR imaging coils and endoscopes.
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