Little Canada, Minn.-based St. Jude said the approval covers MR-conditional labeling for full-body, 1.5-Tesla scans.
“The Nanostim leadless pacemaker is one of the most important advances in the history of pacemaker technology,” chief medical officer Dr. Mark Carlson said in prepared remarks. “The freedom from leads and now the ability for patients with the Nanostim leadless pacemaker to undergo MRI scans are important factors for physicians as they consider treatment options.”
Nanostim 1st won CE Mark approval back in October 2013, triggering a $124 million acquisition by St. Jude, which is running an investigational device exemption trial in the U.S. for the device. The primary safety outcome of the 667-patient Leadless II trial is complication-free rate at 6 months, with secondary efficacy outcomes of therapeutic-range pacing thresholds and R-wave amplitudes at 6 months; and appropriate, proportional rate response during graded exercise at 3 to 6 months.
St. Jude said it anticipates adding more MR-conditional labels to its cardiac rhythm management devices “in the coming months.”