Medtronic nets CE Mark on MRI SureScan pacing leads
Medtronic has received CE Mark and launched the CapSure Sense MRI SureScan pacing leads, which are approved for use during an MRI.
Medtronic introduced the first MR-conditional pacemaker system in the U.S. in February 2011.
As passive-fixation leads (which attach to the heart with small tines), they will give physicians an additional option that is MR-conditional, or designed to be safe for the MRI environment when used per the specified MR conditions for use, according to the Minneapolis-based company.
In August 2011, the FDA approved Medtronic’s investigational device exemption application and clinical trial protocol to begin evaluating the company's updated Advisa DR MRI SureScan pacing system.
Medtronic introduced the first MR-conditional pacemaker system in the U.S. in February 2011.
As passive-fixation leads (which attach to the heart with small tines), they will give physicians an additional option that is MR-conditional, or designed to be safe for the MRI environment when used per the specified MR conditions for use, according to the Minneapolis-based company.
In August 2011, the FDA approved Medtronic’s investigational device exemption application and clinical trial protocol to begin evaluating the company's updated Advisa DR MRI SureScan pacing system.