CE mark For Medtronic’s Next Generation MRI-Friendly Pacing Lead

In short

Medtronic has gained CE Mark approval for its latest-generation MRI-friendly pacemaker lead set, the CapSure Sense MRI SureScan. At 5.3Fr 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.

Background 

Medtronic was first 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 differ in design, using a “passive” fixation system in contrast to the “active” fixation used with the Revo leads.

The FDA gave the company approval in August 2011 to launch clinical trials of its next-generation Advisa MRI-friendly pacemaker, which had been CE marked in June 2009 as we reported here.

Company comments

“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.

The competition

According to MassDevice,  St. Jude Medical  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 be granted in the 1st half of this year, according to St. Jude’s website.

Boston Scientific  similarly expects to launch its Ingenio MRI-friendly pacemaker in U.S. and globally in the 1st half of 2012, according to regulatory filings.

Source: MassDevice, medlatest staff