Data Evaluating MRI-Safe Pacemaker Published
Medtronic released data evaluating their new pacemaker that is purported to be safe with MRI scanners, the EnRhythm MRI SureScan pacing system. Data was recently presented at the European Society of Cardiology Congress in Munich, as reported by Health Imaging.
The study underway is a randomized, controlled, prospective, multi-center trial. Thus far, data has been collected from more than 470 different patients. Over fifty different centers around the world are participating in the trial, including locations in Europe, the U.S., the Middle East, and Canada.
Preliminary data presented focuses on safety and efficacy endpoints. All patients recruited will have an EnRhythm pacemaker placed along with the company’s CapSureFix MRI SureScan pacing leads. Two thirds of the patients will go on to undergo MRI scanning. The primary endpoint is performance of the electrical system.
No complications in pacing secondary to the MRI scan were noted. Specifically, none of the patients experienced either asystole or arrhythmia. Additional study endpoints were met; indicating an appropriate response from the heart to stimulation from the pacemaker.
A small number of patients had complications from implantation of the pacemaker. Those problems were not considered related to the MRI scanning completed. Importantly, the trial is still underway and these results are only preliminary.
September 5, 2008 Related topics: New Technology & Innovation, Quality, Safety, Errors, Cardiology