Subject: FDA
CardioNXT wins FDA nod for heart treatment delivery platform
BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ -- CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping Systemtm, Activate Softwaretm, Sensor Enabled Axis Patient Patchestm, and MultiLink Sensor Enabled Cathetertm.
The CardioNXT technology platform enables the examination of problematic cardiac tissue that is causing arrhythmias and directs the delivery of instruments to target tissue with revolutionary precision and accuracy. The iMap System is the first of its kind to incorporate "dynamic referencing" based 3D Navigation in cardiac procedures. While dynamic referencing is employed in various procedures for brain, spine, ENT and lung surgeries, it is currently not widely used in cardiac procedures. The iMap System achieves cardiac dynamic referencing via a patented combination of dual tracking modalities, electromagnetic and impedance, which utilizes for the first time a dual sensor enabled internal reference catheter, CardioNXT's MultiLink Cathetertm.
"I have used products from and advised many mapping system companies. 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. Treatment paradigms beyond PVI are still to be determined and we need systems like this one to help us evolve treatment strategies." ? Vivek Reddy, MD, Director of Cardiac Arrhythmia Service at Mount Sinai Hospital, NY, NY
"We were the first center in the world to use the full combination of system, software, and catheter in human patients at Homolka Hospital. We are impressed with the system's stability and accuracy and look forward to this technology being more widely available to help us treat patients with cardiac arrhythmias." - Prof. Petr Neu?il, MD, PhD, Chairman of Cardiology at Homolka Hospital, Prague, Czechia
About CardioNXT, Inc.
CardioNXT is a privately held medical technology company focused on building a platform of technologies that will enable physicians to deliver cardiac therapies in a revolutionary targeted and precise manner while also reducing the use of harmful x-ray radiation based imaging. The first market that CardioNXT is pursuing is in the treatment of cardiac arrhythmias such as Atrial Fibrillation. The CardioNXT team is comprised of experienced medtech innovators and the company is funded by savvy industry veterans. The company is located near Boulder, CO, USA, which is a region well known for producing market leading 3D Navigation, Mapping, Electrocautery and Software products, resulting in strong core competencies for disruptive innovation.
SOURCE CardioNXT
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