Imricor Medical Systems said today it won CE Mark approval in the European Union for its Advantage-MR EP recorder/stimulator system, designed to allow for MRI-guided electrophysiology procedures.
The system, along with MR-compatible ablation catheters, will allow operating physicians to perform cardiac ablations using real-time MRI guidance, which the Minneapolis, Minn.-based company said could improve safety and cost-effectiveness.
“Procedures like these have been stuck in x-ray labs since the late 1800’s. With this exciting news, we’ve taken the first step in moving cardiac ablations out of the x-ray lab and into the 21st century. MRI is clearly the future of interventional electrophysiology, and Imricor is the key to that future. With MRI, doctors can, for the 1st time, see the hearts they are working on throughout their procedures; they can see the results of the therapy they deliver; and they can do all this without exposing their patients or themselves to dangerous radiation. At Imricor, we are delivering the MRI compatible devices needed to perform these procedures in the MRI lab and, in turn, transforming the field of electrophysiology,” CEO Steve Wedan said in a press release.
The Advantage-MR EP system handles the display and recording of intracardiac electrograms, pacing function and tip temperature monitoring, and can be used with compatible radiofrequency generators to provide RF during ablation procedures.
According to Imricor, most catheter ablations are guided by x-ray currently, which does not allow the visualization of soft heart tissue. MRI-guided procedures would allow the physician to see the structure of the heart during the procedure, and visualize the results of the procedure in real time.