Medtronic‘s MR-Conditional CapSure Sense MRI SureScan pacing leads received EU clearance.
The passive-fixation leads are the smallest MR-Conditional leads on the market, and provide physicians another option in addition to the previously approved active fixation leads that are anchored right in the heart.
“The CapSure Sense MRI SureScan(R) leads address an unmet clinical need for thoroughly tested MRI conditional passive fixation leads,” said Gianluca Botto, M.D., 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.
Press release: Medtronic Receives CE Mark for Pacemaker Lead That Will Expand Patient Access to MRI Technology
Product page: CapSure Sense MRI