Medtronic leads gain Europe approval

Medtronic on Monday announced European approval of its CapSure Sense MRI SureScan pacing leads -- giving the Fridley-based medical technology maker another chance to increase its market-leading share of MRI-compatible pacing devices.

Called "passive fixation" leads, the newly approved wires attach to the heart with small tines at the end of the device. Medtronic's previously approved leads were "active fixation," meaning they are fastened directly to the heart with a type of screw at the end. Passive fixation leads are a little easier to implant; active fixation leads are a little easier to extract, said Dr. David Steinhaus, medical director for Medtronic.

Medtronic introduced the first MRI-compatible pacemaker system in the world in Europe in 2008 and in the United States in 2011. The newly approved leads give doctors not only the smallest wires available for MRI-compatible systems, but they provide a new option in how doctors attach the lead to the heart.

It is all meant to give doctors more options that are safe for use in an MRI machine. "We do think, particularly in Europe, which has a lot of physicians who like to use passive fixation leads, that it will increase our market share," Steinhaus said. "What this does is it rounds out the portfolio."

Thom Gunderson, a Piper Jaffray analyst, said the cardiac rhythm management sector of medical technology is moving to make all devices MRI-compatible.

Medtronic leads that market and the new approval allowing Medtronic to sell the new leads in 70 countries in Europe and elsewhere will help them grow even more.

Approximately 60 million MRI procedures are performed worldwide each year. An estimated 17 percent of people with pacemakers will need an MRI within the first year of having their device implanted, according to Medtronic. Seventy-five percent of people with pacemakers will need an MRI during their lifetime.