Cardiac Mapping Platform Gets FDA Market Clearance

August 22, 2021

1 minute read

Source / Disclosures

Reddy is a member of the CardioNXT Scientific Advisory Board.

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CardioNXT announced that it has received market approval from the FDA for its cardiac mapping platform for the treatment of arrhythmias.

According to a company press release, the mapping platform (iMap 3D navigation and mapping system, activation software, sensor-activated axis patient patches, MultiLink sensor-activated catheter) is designed for l imaging of cardiac tissue associated with the onset of arrhythmias and directs the administration of treatment. to the target tissue.

Sign outside the FDA headquarters in Washington, DC.
Source: Adobe Stock

According to the release, the system (iMap 3D navigation and mapping system) uses 3D navigation based on “dynamic referencing” via a combination of electromagnetic and impedance tracking modalities and a dual sensor internal reference catheter (catheter MultiLink).

“I have used products and advised many mapping system companies”, Vivek Y. Reddy, MD, director of cardiac arrhythmia services at Mount Sinai Hospital, said in the statement. “My advice to all is that there has to be a tight integration between complex mapping and precise navigation for any heart map to be useful in treating patients, especially complex cases such as persistent atrial fibrillation. CardioNXT took my advice to heart. I am delighted to see the improvements that can be made in the treatment of patients with AF using this technology. Treatment paradigms beyond [pulmonary vein isolation] are yet to be determined and we need systems like this to help us evolve treatment strategies.

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