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Biotronik pacing system gets label expansion

  • The FDA approves the Entovis pacemaker system with ProMRI technology made by Berlin, Germany's Biotronik. The device allows patients to undergo MRI scans with a limited exclusion zone. Entovis patients need only to alert radiology staff and they will verify that they are eligible to undergo the imaging. The company believes that this is a significant advantage over MRI-conditional pacers. The FDA's approval covers both single and dual chamber pacemakers when implanted with Setrox leads.
  • Recent research finds that there is a 50 - 75% probability that patients implanted with a pacemaker or defibrillator will need an MRI at some point in their lives.
  • (BSX) (MDT) (STJ)
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