Sorin Group Wins Japanese Approval for MRI-Safe Pacemaker

Italian devicemaker Sorin Group said Friday that it had approval from Japanese regulators to market its MRI-safe Kora 100 pacing system in the country.

When implanted with Sorin’s Beflex pacing leads, patients with Kora 100 SR and DR pacemakers are able to successfully undergo an MRI scan. Because pacemakers are often implanted in elderly patients who are more likely to have ailments requiring an MRI, this feature represents a major advancement, Sorin said.

Patients with traditional pacemakers either can’t undergo MRI scans or need their devices reset into asynchronous mode to enable a scan, a setting that can leave patients vulnerable to cardiac arrhythmias, Sorin said. Normally, cardiologists adjust the mode prior to a planned scan and then have to change the pacemaker back to synchronous mode after the scan is done, putting patients at risk for longer than necessary.

The Kora 100 has an auto MRI mode which adjusts those settings automatically once an MRI field is detected. After the scan, the pacemaker returns to normal mode.

In European trials, using the Kora in SafeR pacing mode resulted in 51 percent fewer cardiac deaths or heart failure-related hospitalizations. The device received a CE mark in 2013. Sorin completed U.S. trials for the pacemaker in August and is compiling data for an FDA submission. — Kellen Owings