New Medtronic pacemaker safe to use in MRI scans
MUNICH, Aug 31 (Reuters) - A new pacemaker from U.S.medical devices group Medtronic Inc (MDT.N) is safe to use in MRI scanners, according to initial safety and efficacy data unveiled on Sunday.
The SureScan device is the first in the world designed to work safely when patients are inside magnetic resonance imaging (MRI) machines, which are increasingly used to diagnose cancer and neurological disorders.
Around 2 million people have pacemakers in Europe alone but they are prohibited from receiving MRI scans because the devices could malfunction by interacting with the scanner.
The new product from Medtronic, which pioneered the first pacemakers half a century ago, offers a solution for the up to 50 percent of patients worldwide with implanted cardiac devices who are expected to need an MRI scan at some stage.
Results of a clinical trial presented at the annual meeting of the European Society of Cardiology showed no MRI-related complications with the new device and no heart rhythm problems during scanning.
The heart also continued to respond appropriately to the level of electrical stimulation it received, tests found.
A small number of patients did experience implant complications but Medtronic said these were consistent with rates for other pacemaker implant procedures and none were related to the MRI technology.
The positive study findings clear the way for Medtronic to seek approval to launch SureScan in markets outside the United States as early as this year, analysts believe. U.S. approval could follow in 2009. (Reporting by Ben Hirschler; Editing by David Holmes)
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