BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has granted approval for its Entovis pacemaker system with ProMRI® technology. The Entovis system allows patients to undergo Magnetic Resonance Imaging (MRI) scans with a limited exclusion zone.
BIOTRONIK has an unsurpassed legacy of quality engineering with a broad portfolio of state-of-the-art devices and leads. Our independent thinking allows us to pursue long-term visionary innovations that result in meaningful technologies. The BIOTRONIK DX System defines a new paradigm in ICD therapy; it offers dual-chamber diagnostics with a single ICD lead, therefore capturing benefits of both single-chamber and dual-chamber ICDs.
LAKE OSWEGO, Oregon, February 25, 2013—BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced the Food and Drug Administration (FDA) has granted final approval for the BIOTRONIK Lumax 740 DX System. This novel device is a first-in-class implantable cardiac defibrillator (ICD) that utilizes a single lead with atrial sensing capabilities.