Medtronic‘s popular 5076 pacing leads have now been cleared by the FDA for safety under magnetic resonance imaging. By pairing them with the company’s dual-chamber Advisa MRI or Revo MRI SureScan pacemakers, patients can receive completely MRI compatible pacing from Medtronic.
For safe use under MRI, the leads of lengths between 35 cm and 85 cm have been approved.
More from Medtronic’s announcement:
Medtronic has spent more than 17 years studying the MRI environment, and was the first in the industry to introduce a pacemaker system specifically engineered for this purpose. Since its first MR-conditional pacing system was approved in Europe in 2008, Medtronic has continued to design and test its products for safe use during MRI scanning. Advances in computer modeling have allowed Medtronic to vigorously evaluate the 5076 lead across more than 2 million scanning scenarios. [iii] Medtronic also conducted the 5076 MRI Clinical Study, a global, multi-center, study to evaluate the safety and effectiveness of the 5076 lead in the MRI environment.
The 5076 MRI lead is the latest addition to a growing number of Medtronic devices that are approved for MRI access. These include the Medtronic SureScan pacing systems, the SureScan neurostimulation systems for the management of chronic pain, and the SynchroMed® II programmable drug infusion system, which are available worldwide. Additionally, the Evera MRI(TM) SureScan implantable cardioverter-defibrillator (ICD) system is investigational in the U.S.