Life Sciences Insight

FDA greenlights CardioNXT’s 3D heart-mapping platform for arrhythmia treatments

Traditional methods to treat cardiac arrhythmias typically see cardiologists inserting a catheter into the heart to measure electrical impulses and determine where in the tissue the abnormal rhythm is originating—often with the help of radioactive dyes and an X-ray machine—then apply heat or extreme cold to the tissue to block that rhythm.

And while ablation remains the go-to technique to treat atrial fibrillation and other arrhythmias, CardioNXT is aiming to both boost the precision of the entire process and reduce the amount of radiation exposure to patients with a sensor-equipped, 3D mapping technology platform.

The platform comprises several components. The physical tools include wearable patches and an internal reference catheter, both of which are outfitted with electromagnetic and impedance sensors to identify the exact location of the tissue causing an arrhythmia.

The readings from those sensors are processed by the platform’s iMap and Activate software systems, which not only build a comprehensive model of the heart but also provide 3D guidance to cardiologists as they move the catheter throughout the organ to begin the ablation procedure.

CardioNXT announced this week that the platform has received marketing clearance from the FDA, allowing the Colorado-based company to begin rolling out the technology to healthcare providers across the U.S.

Though many other software developers have created their own heart-mapping technologies, according to CardioNXT, its system is one of the first to provide 3D navigation akin to the “dynamic referencing” already used in brain, spine, lung and respiratory procedures, a system that has not yet been widely introduced to cardiology.

In the last five years, the company has raised just over $3.5 million in venture funding. Its most recent financing round, in June 2017, was led by former Medtronic CEO William Hawkins and Jim Bullock, who led Atritech until its sale to Boston Scientific.

CardioNXT’s competitors in the heart-mapping space include medtech giants like Medtronic, Boston Scientific and Abbott.

Medtronic’s CardioInsight system, for one, combines electrocardiogram and CT scan data to produce 3D, multichamber maps of the heart, while Boston Scientific’s Rhythmia HDx relies on a high-definition mapping catheter and a proprietary software algorithm to draw up its own complex cardiac maps.

Smaller startups have also hopped on the bandwagon. HeartFlow, which is currently preparing to go public by way of a $2.4 billion reverse merger, has designed a suite of artificial intelligence algorithms to turn standard CT scans into a detailed 3D map that can pinpoint quantitative symptoms of coronary artery disease.

And former Fierce 15 honoree Acutus Medical received an FDA clearance of its own last year for a software system that can map out the heart and visualize atrial rhythms within just three minutes.

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