Medical device titan Medtronic (NYSE:MDT) landed Japanese regulatory approval for its Advisa MRI SureScan pacing system, which allows patients to have full-body scans without positioning limitations during the MRI scanner procedure.
"Until recently there was a significant unmet need for patients with pacemakers to have access to MRI technology," said Dr. Ken Okumura, professor at Hirosaki University and president of the Japanese Heart Rhythm Society, in prepared remarks. "Now physicians and patients have a choice of pacing systems that allow access to the invaluable benefits of MRI technology."
Medtronic’s Advisa MRI pacing system has a proprietary managed ventricular pacing algorithm, which could reduce unnecessary ventricular pacing by 99%, the company said. The new system includes an Advisa MRI device and two CapSureFix MRI SureScan leads that muse be used together.
The SureScan pacemaker system, which was introduced in Europe in 2008, allows patients receive MRI scans that normally pose a threat to traditional pacemaker function and patient safety, according to the press release.
Japan is the world’s 2nd-largest market for medical devices. According to the press release, approximately 400,000 people in Japan have implanted pacemakers, and they have been contraindicated from receiving MRI scans until the availability of Medtronic’s SureScan pacing systems.
The Advisa DR MRI SureScan pacing system is not available for sale in the U.S. Medtronic’s Revo MRI SureScan pacing system received FDA approved in February 2011.
