Medtronic has announced the launch and CE mark approval of the CapSure Sense MRI SureScan pacing leads for use during magnetic resonance imaging.
According to a company release, the newly approved leads are the smallest MR–conditional leads available in the world. 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 specified MR conditions.
“The CapSure Sense MRI SureScan leads address an unmet clinical need for thoroughly tested MRI conditional passive fixation leads,” said Gianluca Botto, director of EPS Unit at St Anna Hospital in Como, Italy. “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.”
To assure the safety of patients and the effectiveness of the patients’ pacing therapy, the CapSure Sense MRI leads were tested in more than 400,000 scenarios that evaluated different patient body types, scanning locations, MRI scanner types and lead lengths.