Cardiac mapping platform gains FDA marketing clearance
CardioNXT announced it received marketing clearance from the FDA for its cardiac mapping platform for the treatment of arrhythmia disorders.
According to a company press release, the mapping platform (iMap 3D Navigation and Mapping System, Activate Software, Sensor Enabled Axis Patient Patches, MultiLink Sensor Enabled Catheter) is designed for the imaging of cardiac tissue associated with causing arrhythmias and directs the delivery of treatment to the target tissue.
According to the release, the system (iMap 3D Navigation and Mapping System) uses “dynamic referencing” based 3D navigation via a combination of electromagnetic and impedance tracking modalities and a dual sensor enabled internal reference catheter (MultiLink Catheter).
“I have used products from and advised many mapping system companies,” Vivek Y. Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital, said in the release. “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 atrial fibrillation. CardioNXT has taken my advice to heart. I’m excited to see the improvements that can be made in the treatment of AF patients with this technology. Treatment paradigms beyond [pulmonary vein isolation] are still to be determined and we need systems like this one to help us evolve treatment strategies.”