BIOTRONIK, a leader in cardio- and endovascular medical technology, today announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.
LAKE OSWEGO, Oregon, December 22, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that it has received Food and Drug Administration (FDA) approval for use of its latest family of implantable cardioverter defibrillator (ICD) systems with magnetic resonance imaging (MRI) scans. BIOTRONIK ProMRI® technology allows patients with approved device systems to have 1.5 Tesla MRI scans without an exclusion zone. ICD patients will have expanded access to MRI diagnostic scans, which can be critical for diagnosing conditions such as stroke, brain and cardiac tumors or orthopedic injuries.
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.