Medtronic has started a clinical trial to confirm the safety and efficacy of its EnRhythm MRI SureScan pacing system, said to be the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions. The includes a dual-chamber pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI). The first implant in the U.S. clinical trial was performed by Brian Ramza, M.D., Ph.D., director of Electrophysiology Laboratory Services at the Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, Mo.

Currently, individuals with implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices are prohibited from receiving MRI scans, since MRI machines may interact with traditional systems, potentially compromising therapy and patient safety.

Extensive research and design went into the EnRhythm MRI SureScan pacing system to address and mitigate interactions between the pacing system and the MR environment. The system includes modified hardware to minimize the level of energy transmitted through the lead/device connection point. The pacemaker also includes a new SureScan feature that can be programmed “on” before an MRI scan to eliminate the impact of MRI-generated electrical noise, which can impact pacing therapy. The device and leads also contain radiopaque marks, viewable via X-ray, to indicate that the system is MR-Conditional (a term identifying a device that may be used during an MRI under specified scanning conditions). The CapSureFix MRI SureScan leads are modified versions of the active-fixation Medtronic CapSureFix Novus leads, and are designed to decrease the risk of overheating during an MRI scan without limiting the ability to conduct therapy.