Biotronik said it’s planning a mid-year launch in Europe for its Iforia MRI-safe pacemaker now that EU regulators have given the device CE Mark approval.
The German medical device company said the Iforia is the world’s 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.
"Safety and reliability are the foundation of all of our new technologies and innovations," Biotronik international president Christoph Böhmer said in prepared remarks (PDF). "Iforia offers enhanced diagnostic possibilities with the highest reliability and unsurpassed longevity."
"European market release of the Iforia series is expected in midyear 2013," according to the release.