Schering AG, Germany announced the EU approval for its contrast agent Gadovist 1.0 for use in Magnetic Resonance Angiography (MRA). The new indication was approved in the variation procedure with Germany as reference member state. At the same time, approval of this additional indication was also received in Switzerland. Gadovist 1.0 is marketed since 1999 for Magnetic Resonance Imaging (MRI) of brain and spine in Europe and numerous other countries.
“Gadovist 1.0 is the first extracellular contrast agent that receives EU approval in this indication. We are proud to present another “first” in MR contrast media, which underlines once again our leadership in contrast media innovation”, said Michael Rook, head of diagnostics & radiopharmaceuticals at Schering AG. “MRA has emerged as an exciting diagnostic procedure for imaging of vascular disease and it enjoys increasing appreciation by radiologists and patients. Indeed, it is one of the fastest growing fields in diagnostic imaging. MRA with Gadovist 1.0 is safer, considerably less invasive and less expensive than the current standard examinations with X-Ray Angiography, which require the use of catheters.“
MRA offers a minimally invasive technology for the detection of vascular disease. Vascular disease is a major cause of physical disability and death in the industrialized world. It includes stenotic or occlusive changes of the arteries leading to infarction, thrombosis and embolism. Gadovist 1.0 can be used for diagnosis, therapy planning and follow-up of vascular disease.
With Gadovist 1.0 Schering provides a highly concentrated contrast medium with a good safety profile and advantages particularly in advanced MRI applications such as MRA, fast dynamic and perfusion imaging. Conveniently packaged in pre-filled syringes, Gadovist 1.0 provides excellent bolus characteristics at small volumes, which results in high diagnostic efficacy in the target region.
Gadovist 1.0 also has the potential to meet new imaging needs that will evolve from the further development of MRI as a diagnostic tool. This development is characterized by an increasing use of faster image acquisition and 3-D data processing. One of the potential fields is the use in cardiac MRI, in which Gadovist 1.0 is currently under investigation.