Medtronic has received CE mark approval for its CapSure Sense MRI SureScan pacing leads.
The newly approved leads are the smallest MR-Conditional leads available and are passive fixation leads, which attach to the heart with small tines. MRI pacing leads offer physicians an additional option that is MR-Conditional, or designed to be safe for the MRI environment when used as per the specified MR conditions.
The CapSure Sense MRI leads have been tested for safety and efficacy in more than 400,000 scenarios that assessed different patient body types, scanning locations, MRI scanner types and lead lengths.
St. Anna Hospital in Como, Italy, EPS Unit director Gianluca Botto said the CapSure Sense MRI SureScan leads address an unmet clinical need for thoroughly tested MRI conditional passive fixation leads.
"With this new lead, there is now a full portfolio of options available for physicians and their patients, when this lead is combined with an MR-Conditional device," Botto added.
Medtronic senior vice president and Cardiac Rhythm Disease Management business president Pat Mackin said now patients and physicians will have access to MRI passive leads approved for full body MRI scans. The company said with around 60 million MRI procedures performed worldwide each year, there has been an increasing demand for MR-Conditional pacing systems.
Headquartered in Minneapolis, in the US, Medtronic offers medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Image: Medtronic World Headquarters, Fridley, Minnesota. Photo: Bobak Ha'Eri.