Medtronic, a healthcare products company based in Minneapolis, Minnesota, announced that it received approval from the United States Food and Drug Administration for its Advisa MRI pacemaker system. According to a press release by the company, this will be the second MRI-safe pacemaker system with regulatory approval in the United States.
Less than two years ago, Medtronic also won approval from the FDA for its SureScan pacing system. This was the first MRI-safe pacemaker to be approved in the United States. In 2011, Medtronic gained CE Mark clearance in the European Union for its Revo device. The company was able to win approval by aggressively pursuing research and development of its Advisa MRI-safe pacer.
Medtronic will not maintain its position as the only player in the MRI-safe pacemaker market for long. As of now, St. Jude Medical is conducting a clinical trial for its Accent MRI. The Accent MRI is a full-body MRI-safe pacemaker that allows widespread use of MRIs of many parts of the body. In addition, Biotronik won FDA approval last month for a clinical trial of its MRI-safe pacemaker system.
Since MRI-safe pacemakers must pass through more regulatory loops than traditional pacemakers, gaining FDA approval for the Advisa device is a huge step forward for the company. In contrast, Medtronic has been marketing SureScan MRI-safe pacemakers in Europe for the past five years.