Medtronic (NYSE:MDT) won CE Mark approval in the European Union for its latest-generation MRI-friendly pacemaker lead set, the CapSure Sense MRI SureScan.
The leads are the smallest available in the world that allow patients to undergo MRI procedures without risking damage to their devices from the scanners’ powerful magnets.
Medtronic was 1st to bring an MRI-friendly pacemaker to the U.S. market when it won an FDA green light for the Revo MRI SureScan pacemaker and its leads in February 2011.
The new CapSure leads use a "passive" fixation system, as opposed to the "active" fixation used with the previous generation of Revo leads.
"Active leads use something within the lead to attach them; usually it’s a screw where the lead is actually attached to the heart by screwing a small screw into the heart muscle," Dr. David Steinhouse, vice president & medical director of Medtronic’s CRDM division, told MassDevice.com. "Passive fixation leads have what are called ‘tines’ in them; it’s a little bit like a barb or arrow, where it gets stuck in the heart as opposed to being screwed in the heart."
The new leads "allow physicians who are used to using passive fixation leads to be able to implant and still be MRI-compatible," Steinhouse added.
Medtronic CEO Omar Ishrak credited the Revo system with adding 4 points of share gainin the U.S. pacing market to its 3rd quarter earnings.
"Our U.S. pacing business grew 8%, driven by the ongoing success of our Revo MRI SureScan pacemaker," Ishrak said during a conference call with analysts. "Revo continues to command a mid-teens percentage price uplift, which is offsetting pricing pressure in the pacing market."
The Fridley, Minn.-based med-tech titan’s Revo pacemaker first penetrated the global market when it won CE Mark as the EnRhythm MRI SureScan system in November 2008.
The FDA gave Medtronic the go-ahead in August 2011 to launch clinical trials of its next-generation Advisa MRI-friendly pacemaker.
Rival St. Jude Medical (NYSE:STJ) launched its own MRI-friendly Accent pacemaker and Tendril MRI lead in the E.U. in April 2011; investigational device exemption for the U.S. market is expected to drop in the 1st half of this year, according to St. Jude’s website.