Medtronic receives CE Mark for CapSure Sense MRI SureScan leads

Medtronic has been granted CE Mark approval for its new CapSure Sense MRI SureScan pacing leads, which will now be launched across Europe.

The leads are designed to be used during magnetic resonance imaging (MRI) scanning and are the smallest MR-conditional leads available in the world, with clinical studies demonstrating their safety and effectiveness.

Because they are passive-fixation leads that attach to the heart using small tines, they can provide a viable alternative to the range of active-fixation leads currently available from Medtronic and offer clinicians a wider range of options.

They have been tested in more than 400,000 scenarios, including trials that assessed different body types, scanning locations, MRI scanner varieties and lead lengths.

Pat Mackin, president of the cardiac rhythm disease management business and senior vice-president at Medtronic, said: "Now patients and physicians will have access to MRI passive leads approved for full-body MRI scans."

Last week, the company published positive data from a new trial of its MiniMed Paradigm System with Low Glucose Suspend automation technology, which it believes could be useful in the development of an artificial pancreas.