Biotronik Gets FDA Approval for Use of ICD Systems With MRI Scans
Cardiovascular medical technology provider Biotronik has won FDA approval for use of its newest implantable cardioverter defibrillator systems with magnetic resonance imaging scans.
With access to MRI scans, patients can be diagnosed more easily with conditions such as stroke, brain and cardiac tumors or orthopedic injuries, according to Biotronik.
The company’s ProMRI technology enables patients with approved device systems to have 1.5 Tesla MRI scans without an exclusion zone.
Approval of Biotronik’s ProMRI ICD family includes the Iperia DR-T in both DF-1 and DF4 configurations, as well as the Iperia DX System, an ICD hybrid that combines the benefits of both single- and dual-chamber devices. — Michael Cipriano