The Food and Drug Administration gave Medtronic approval to introduce the Advisa SR MRI SureScan sing-chamber pacemaker in the United States. The MRI-conditional device comes with a matching 5076 MRI lead, the combination allowing for magnetic resonance scans on any part of of the body, given a few precautions.
Besides its compatibility with MR scans, the Advisa SR MRI has been updated with additional information management and storage, as well as a battery life 35 longer than the Adapta pacemaker.
“MRI is a vital diagnostic tool that was not available to pacemaker patients before Medtronic released the world’s first MR-conditional pacing system in 2008,” said Brian Urke, vice president and general manager of the bradycardia business at Medtronic. “Through our work with clinicians, Medtronic MR-conditional pacing systems have been evaluated in four clinical studies with more than 3,600 patients, and today we offer the most extensive portfolio of MR-conditional pacing devices and leads available in the U.S.”
The Advisa single chamber pacemaker is the latest addition to a growing number of Medtronic devices that are designed for MRI access including the Advisa DR MRI®and Revo MRI® dual chamber SureScan pacing systems, the Reveal LINQ®Insertable Cardiac Monitoring (ICM) system, SureScan neurostimulation systems and the SynchroMed® II programmable drug infusion system which are available worldwide.
Product page: Advisa MRI SureScan Pacing System…