FDA Clears Technology Platform for Examining Cardiac Tissue

The mapping system incorporate referencing based on 3D navigation, similar to what is used for brain, spine, ENT, and lung surgeries.

The US Food and Drug Administration (FDA) has granted market clearance to CardioNXT for new platform technology for the examination of problematic cardiac tissue causing arrhythmias and directing the delivery of instruments to target tissue with precision and accuracy.

The Platform

The platform is set to include the iMap 3D Navigation & Mapping System, Activate Software, Sensor Enabled Axis Patient Patches, and MultiLink Sensor Enabled Catheter.

The iMap System can incorporate “dynamic referencing” based on 3D Navigation in cardiac procedures, similar to how the technology has been used for brain, spine, ENT, and lung surgeries.

The Benefit

The system achieves cardiac dynamic referencing through a patented combination of dual tracking modalities, electromagnetic, and impedance, which utilizes the MultiLink Catheter, a dual sensor enabled internal reference catheter.

"I have used products from and advised many mapping system companies,” Vivek Reddy, MD, Director of Cardiac Arrhythmia Service at Mount Sinai Hospital, said in a statement. “My advice to all is that there must be a tight integration between complex mapping and accurate navigation in order for any map of the heart to be useful in the treatment of patients, especially complex cases such as persistent AFib.

“CardioNXT has taken my advice to heart. I'm excited to see the improvements that can be made in the treatment of AFib patients with this technology,” he added. “Treatment paradigms beyond PVI are still to be determined and we need systems like this one to help us evolve treatment strategies.”