LAKE OSWEGO, Ore.--(BUSINESS WIRE)--BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that Phase B of its ProMRI® study has completed patient enrollment and concluded all planned scans. This phase of the study is investigating the safety of Entovis pacemakers in patients who undergo full-body magnetic resonance imaging (MRI) scans, including cardiac and thoracic spinal scans.
The BIOTRONIK ProMRI study consists of a series of ground-breaking MRI compatibility trials; all intended to increase cardiac device patients’ access to this diagnostic tool. Phase A of the trial resulted in FDA approval of Entovis pacemaker systems for MRI scans with an exclusion zone. Phase C, still ongoing, incorporates Iforia ICD and DX systems into the list of devices being investigated for full-body MRI scans.
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