Medtronic has announced CE Mark approval and the European launch of its Advisa and Ensura SR MRI SureScan single chamber pacemaker devices.
The company has obtained CE Mark approval for the Advisa and Ensura SR MRI SureScan pacemakers for magnetic resonance imaging (MRI) scans positioned on any region of the body.
According to Medtronic, the Advisa and Ensura SR MRI devices provide single chamber pacing engineered with the same SureScan technology used in other Medtronic MR-Conditional pacemakers and implantable cardioverter-defibrillators.
The two single chamber pacemaker devices features 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 labeled lead that must be used together to be considered MR-conditional.
University Hospital Lausanne in Switzerland director Dr Juerg Schwitter said that for patients with chronic atrial fibrillation and intermittent AV 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.
Medtronic senior vice president and Cardiac Rhythm Disease Management business president Pat Mackin said that the company has remained committed to developing devices that are approved for MRI since its release of the world’s first MR-conditional pacing system in 2008, and still today the company offers the only pacemaker system FDA-approved for MRI scans positioned on any region of the body.
The Advisa and Ensura SR MRI single chamber pacemaker devices are not approved in the US.
Image: Medtronic’s Advisa SR MRI SureScan pacemaker. Photo: Courtesy of Medtronic, Inc