CE mark for Advisa and Ensura SR MRI SureScan pacemaker systems


Medtronic has announced CE mark approval and commercial launch of the Advisa and Ensura SR MRI SureScan single-chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI) scans positioned on any region of the body. These devices are not approved in the United States.

“For patients with chronic atrial fibrillation and intermittent atrioventricular block, the availability of the Advisa or Ensura MRI single-chamber pacemakers provides physicians with more options when determining the best treatment plan for their patients,” says Juerg Schwitter, director of the CMR Center at the University Hospital Lausanne in Lausanne, Switzerland. “It is imperative that patients with pacemakers receive access to MRI scanning for any region of the body.”

Advisa and Ensura SR MRI pacemakers deliver single-chamber pacing engineered with the same SureScan technology used in other Medtronic MR-conditional pacemakers and implantable cardioverter-defibrillators (ICDs), while adding features such as improved diagnostic information and storage, as well as a 35% improvement in battery longevity (when compared to the Adapta-single chamber pacing system). The new systems include an Advisa or Ensura SR MRI device with any SureScan labelled lead, which must be used together to be considered MR-conditional.