The Food and Drug Administration has given investigational device exemption (IDE) approval to Medtronic to begin evaluation of its Advisa DR MRI SureScan pacing system.
Medtronic will conduct a prospective, randomised, controlled, non-blinded, multicentre clinical trial to confirm the safety and effectiveness of its second generation pacing system, in the clinical magnetic resonance imaging setting under specified conditions.
“This clinical trial is an important milestone toward providing another innovative pacing system option for patients who may need access to the potentially life-saving benefits of magnetic resonance imaging technology during the lifetime of their device,” said Edward J Schloss, medical director of electrophysiology, The Christ Hospital, Cincinnati, USA.
Schloss implanted the first patient in the USA with the investigational Advisa MRI system as part of the clinical trial through The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital.
Until FDA approval of Medtronic’s first-generation Revo MRI SureScan pacing system in February 2011, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.
“The FDA approval of the Advisa MRI system study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the magnetic resonance imaging environment,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.
The Advisa DR MRI SureScan pacing system is not yet approved by the FDA for US commercial distribution. In Europe, this pacing system has been available since 2010.