A Medical Device Daily

Medtronic (Minneapolis) reported the start of a U.S. clinical trial to confirm the safety and efficacy of the EnRhythm MRI SureScan pacing system, which it said is the first pacemaker system to be developed and tested specifically for safe use in MRI machines under specified scanning conditions.

The pacing system consists of the dual-chamber SureScan pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI). Currently, individuals with implanted cardiac devices such as pacemakers, ICDs and CRT devices are prohibited from receiving MRI scans, since MRI machines may interact with traditional systems, potentially compromising therapy and patient safety.

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).

“Medtronic understood the need to provide device patients with the means to undergo this commonly used diagnostic tool, which is why we’ve thoroughly researched the risks to patients and designed a pacemaker and lead system from the ground up that will enable patients to benefit from MRI technology.” said Pat Mackin, president of the company’s Cardiac Rhythm Disease Management business.