New Data Out Of Cleveland Clinic Shows BioSig PURE EP May Be Used For More Precise Approach For $6 Billion Annual Atrial Fibrillation Market

Cleveland Clinic researchers presented data from three new studies involving BioSig Technologies’ BSGM proprietary PURE EP Platform at the annual Heart Rhythm 2023 meeting in New Orleans, LA last week. The platform’s precision signal-capturing technology is meant to improve the speed, accuracy and precision of cardiac ablation, a widely-used surgery to treat atrial fibrillation. All three studies showed significant improvements over the conventional methods used for the procedure, putting BioSig on track for a successful commercial launch of the platform in a global cardiac ablation market projected to exceed $14 billion by 2032. 

75,000 Ablation Procedures Are Performed Every Year In The U.S. 

According to the Centers for Disease Control (CDC), approximately 12.1 million Americans will have atrial fibrillation (AF) by 2030. AF is responsible for over 750,000 hospitalizations in the United States every year according to the National Institutes of Health. AF is also a serious risk factor for strokes, increasing a patient’s risk almost fivefold and causing those strokes to be more severe than those in patients without AF. 

The standard of care for AF includes medication to help regulate the patient’s heart rate, blood thinners to reduce the risk of stroke, and, if doesn’t get better, a surgical procedure called cardiac ablation. This results in healthcare costs of about $63,000 per patient per year, or $28.4 billion nationwide. As more patients are diagnosed with the condition, those costs are expected to reach $45.4 billion by 2030. 

The current cardiac ablation procedure involves inserting a catheter through a blood vessel all the way into the heart. The end of the catheter is fitted with sensors that can apply radiofrequency energy to create heat that can scar the surrounding area of the heart and block the abnormal electrical signals that are causing the irregular heartbeat. 

The Ablation Index was the last big breakthrough in the field, shortening the procedure time, improving accuracy and reducing the post-surgery relapse rate by nearly half. Developed by Biosense Webster, a subsidiary of Johnson & Johnson JNJ, the index provides a 3D mapping system to visualize the surgery so doctors can accurately and quickly place the catheter in the right position. In addition, AtriCure Inc ATRC, Abbott ABT and Medtronic MDT are other notable companies in the space.

PURE EP Platform Captures Real-Time Feedback Other Tech Misses

While the Ablation Index uses surrogate measures including contract force, power and time, PURE EP uses raw unipolar signals to generate real-time feedback. In the past, studies have suggested that using these unipolar signals could improve the accuracy of ablations, but actually capturing those signals proved impractical as there was too much noise interference from the operating room as well as the radiofrequency equipment used in the procedure. 

The PURE EP platform’s proprietary hardware and software can dampen noise interference and pick up the unipolar signal clearly and in real time with a level of precision that other platforms reportedly can’t achieve.

To understand how much of a difference this improved signal-capturing tech made in the operating room, the three studies presented at Heart Rhythm 2023 each compared a new cardiac ablation procedure using BioSig’s PURE EP Platform to the current best-in-class Ablation Index-guided procedure. 

In the first study, the new procedure was able to achieve identical results in both swine and human models in a fraction of the time. Where the standard ablation index-guided procedure had an ablation time of 24 seconds, the PURE EP-guided procedure’s ablation time was just eight seconds. 

In the second study, doctors performed the surgery without the 3D mapping system traditionally used. Instead, they were able to accurately place and space lesions in swine models guided only by the PURE EP Platform’s unipolar morphology. 

In the third study, researchers found that the platform could successfully differentiate between healthy tissue and scar tissue, allowing doctors to better measure lesions for more precise lesion placement. 

Already used in several hospitals across the country, BioSig is optimistic that the non-invasive platform could see even wider spread adoption of the technology following the release of these three studies demonstrating the improved speed, accuracy and precision of cardiac ablations done with the PURE EP Platform.

Featured photo by Ali Hajiluyi on Unsplash.

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