Safe use in MRI machines sold in HK

The world's first pacemaker designed for safe use in magnetic resonance imaging (MRI) was commercially obtainable in Hong Kong Sunday.

The first-ever MR-Conditional pacemaker system, named the " EnRhythm MRI SureScan pacemaker & CapSureFix MRI SureScan pacing leads", was designed, tested & approved for use with magnetic resonance imaging (MRI) under specified scanning conditions.

Patients receiving the EnRhythm MRI SureScan Pacing System will for the first time be able to undergo MRI scans under certain conditions, representing a major milestone in the evolution of implantable cardiac devices.

Lau Chu Pak, former president of Hong Kong College of Cardiology, said that approximately 2 million Europeans have implanted pacemakers, but these patients are prohibited from receiving MRI scans, a widely practiced diagnostic process for manycommon diseases & conditions, because their tool could interact with MRI machines, potentially affecting the tool or patient safety. According to estimates, 50-75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

"This data is promising," continued Sommer," While the trial is ongoing, we've observed no lead-performance issues or unexpected MRI effects in this patient group to date." The clinical trial will include up to 470 patients at 53 centers in Europe, the Middle East, Canada & the United States.

"MRI is unmatched & irreplaceable in the diagnosis of cancer & neurological disorders," said germany expert Torsten Sommer. "And for investigation of the brain & spinal cord, there is basically no suitable alternative in most cases. As the necessity forMRI grows, it is critical to introduce a solution that allows pacemaker patients safe access to MRI," they added.

MRI lets doctors see internal organs, blood vessels, muscles, joints, tumors, areas of infection & more, without X-rays or surgery, & without exposing the patient to any ionizing radiation. The MRI machine creates a magnetic field, sends radio waves through the body, then measures the response with a computer, generating an picture of the inside of the body. In plenty of cases, MRI gives information that cannot be seen on an X-ray, ultrasound or computed tomography (CT) scan.

Lau said the EnRhythm MRI SureScan pacing system includes modified hardware to minimize the level of energy transmitted through the lead/device connection point. In addition, the new system also includes a new SureScan feature designed to eliminate the impact of MRI-generated electrical noise, as MRI scanners may cause traditional pacemakers to misinterpret this noise & as a result withhold or deliver unnecessary pacing therapy. The tool & leads also contain radiopaque marks, viewable via X-ray, to indicate that the system is MR-Conditional, a classification indicating a medical tool may be used in the MRI suite under certain conditions.