Medtronic ($MDT) has launched its CapSure Sense MRI SureScan pacing leads internationally after securing CE Mark approval. The leads are approved for use during MRI procedures. And this is very good news, as MRI procedures are indicated for 17% of pacemaker patients within 12 months of device implant, according to a company statement.
The leads are the smallest MR-conditional leads available in the world. An added bonus is that they are passive-fixation leads, which attach to the heart with small tines. Previous Medtronic MR-conditional leads fastened directly into the cardiac tissue.
To show their safety and efficacy, the leads were evaluated in different patient body types, scanning locations, MRI scanner types and lead lengths. "Now patients and physicians will have access to MRI passive leads approved for full body MRI scans," explains Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior VP at Medtronic, in a statement. "This is a major step forward in addressing both patient access and providing physician options."
Last year, the FDA cleared Medtronic's Revo MRI SureScan pacing system, the first and only pacemaker in the U.S. specifically designed for use in an MRI environment.
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