On 18 October, Medtronic announced the Japanese regulatory approval and launch of the Advisa DR MRI SureScan pacing system. The Advisa MRI system is the first and only MR-Conditional pacemaker available to patients in Japan.
With the Advisa MRI system, pacemaker patients will have access to full body scans, without positioning limitations in the magnetic resonance imaging (MRI) scanner. Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in Japan. The system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, which must be used together.
“Until recently there was a significant unmet need for patients with pacemakers to have access to MRI technology,” said Ken Okumura professor and chief, Department of Cardiology, Graduate School of Medicine, Hirosaki University and president of the Japanese Heart Rhythm Society. “Now physicians and patients have a choice of pacing systems that allow access to the invaluable benefits of MRI technology.”
The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by extensive computer modeling and clinical studies, as well as real-life data.
According to Gillis AM, et al (PACE, July 2006; 29(7):697-705) 50 to 75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.
The Advisa DR MRI SureScan pacing system is not yet available in the USA. The Revo MRI SureScan pacing system was FDA approved in February 2011.