Medtronic has announced the US Food and Drug Administration (FDA) approval and commercial launch of the Advisa SR MRI SureScan single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging (MRI) scans positioned on any region of the body without restrictions. The new system includes the Advisa SR MRI pacemaker and a SureScan lead, which must be used together to be considered MR-conditional.
It is estimated that 50–75% of patients with implantable cardiac devices will need an MRI scan over the lifetime of their device. Until the approval of MR-conditional pacemakers, patients with implanted devices were typically denied access to MRI procedures because of the potential for harmful interaction between the device and the MRI scanner.
In addition to delivering single-chamber pacing with the same SureScan technology used in other Medtronic cardiac devices, the new Advisa SR MRI pacemaker has improved diagnostic information and storage, and a 35% improvement in battery longevity (when compared to the Adapta single chamber pacing system).
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 system, SureScan neurostimulation systems and the SynchroMed II programmable drug infusion system which are available worldwide.