Artificial city

First US Patients With Persistent Cardiac Arrhythmias Treated Using Volta Medical’s Artificial Intelligence-Based Analysis

  • A new FDA-approved and CE-certified medical device is designed to help cardiologists identify heart abnormalities in patients undergoing ablation therapy for persistent and drug-resistant atrial fibrillation (AF), a common heart disease.

  • New York-Presbyterian Queens, Northwell Health’s Lenox Hill Hospital in New York, and Ascension St. Vincent’s Riverside, Jacksonville, Florida are the first US medical centers to use Volta’s VX1 product. All three are participating in an international, randomized, controlled clinical trial to evaluate the results of VX1-guided ablation compared to standard ablation. They actively recruit patients for the trials.

MARSEILLE, France and PROVIDENCE, RI, December 21, 2021 (GLOBE NEWSWIRE) – Volta Medical, a pioneering healthcare technology company that develops software solutions based on artificial intelligence (AI) to treat cardiac arrhythmias , today announced the launch of its industry-leading product, VX1, at three major US hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital in both New York City and Ascension St. Vincent’s Riverside, Jacksonville, Fla., Are the first US hospitals to implement VX1, which is designed to improve outcomes for patients with atrial fibrillation (AF) ablation procedures.

All three hospitals are also recruiting AF ablation patients to participate in an international randomized controlled clinical trial to evaluate the outcome of VX1-guided ablation compared to standard ablation. The VX1 is licensed as a medical device by the United States Food and Drug Administration and CE certified by the European Union.

VX1 is the first commercially available AI software to help clinicians address high failure rates in the use of ablation for the treatment of persistent and drug-resistant AF. AF, characterized by an irregular and chaotic heart beat (cardiac arrhythmia), can lead to more serious health problems such as heart failure and stroke. During AF ablation, a specialist cardiologist known as an electrophysiologist inserts catheters through blood vessels in the heart to burn or freeze tissue that causes abnormal electrical signals in the upper chamber or the upper chamber. headset. The procedure creates scars that restore a normal heart rhythm.

The VX1 system analyzes the electrical signals measured during the procedure and identifies anomalies in real time. The VX1 is versatile and can be installed in most operating rooms and is compatible with major multipolar catheters and mapping systems.

“We are excited about the potential this approach has to help our patients living with persistent and drug-resistant AF,” says Seth Goldbarg, MD, director of cardiac electrophysiology at New York-Presbyterian Queens and assistant professor of medicine clinic at Weill Cornell Medicine. “The VX1 system can help us tailor our procedures to each patient by more precisely identifying the optimal ablation locations in real time. “

“To date, electrophysiologists have relied on their own experience and simple analytical tools to make decisions about ablation locations rather than using robust measurable electrical anomalies,” said Theophile Mohr Durdez, CEO and co-founder of Volta Medical. “To date, we have supported around 500 procedures with our AI-based analysis and the feedback has been excellent. We are convinced that this approach can help revolutionize the field and prove to significantly improve patient outcomes. “

To this end, Volta Medical initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation versus conventional anatomical ablation approaches. The international multicenter trial will involve 25 sites and 342 patients and is expected to report results in 2024.

“Treating the large number of patients with severe, persistent and drug-resistant forms of AF remains an ongoing challenge for clinicians, as current treatment strategies cannot offer predictable efficacy,” said Stavros Mountantonakis, MD, director of AF. Cardiac Electrophysiology at Lenox Hill Hospital, part of Northwell Health. “We find VX1 to be a valuable tool in our ablation procedures, and we hope the TAILORED-AF trial will validate its use as a breakthrough innovation to ensure improved long-term outcomes for these patients. “

“Our patients with persistent and drug-resistant AF face many ongoing challenges, and we are delighted to propose the VX1 System as a promising new treatment strategy for their ablation procedures,” said Saumil R. Oza, MD, cardiologist at Ascension. St. Vincent’s Riverside in Jacksonville, Florida. “Current ablation techniques cannot offer predictable efficacy, which is why the VX1 system shows so much promise. Because it allows us to accurately identify the optimal ablation locations for each patient, we are confident that this will lead to better treatment results.

Dr Seth Goldbarg receives compensation for his role on Volta Medical’s Scientific Advisory Board and the Tailored AF Trial Steering Committee. Dr Goldbarg also owns shares in Volta Medical.

About atrial fibrillation (AF)

It is estimated that 6.1 million people in the United States suffer from AF with projections reaching nearly 12.1 million by 2030.4, 5 Globally, it affects more than 33 million people.1 Symptoms include palpitations, dizziness, and shortness of breath. In some patients, AF can lead to heart failure.1 AF is not only an extremely expensive public health problem, but also a major risk factor for stroke, posing a risk 4 to 5 times higher than for the general population.6 AF is usually treated with drugs that regulate or slow down the heart rate.2 For patients who cannot tolerate or are resistant to antiarrhythmic drug therapy, ablation is the current standard of care.2 Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heart rhythm. However, the effectiveness of this approach largely depends on the experience and intuition of the electrophysiologist. With 50% of patients with persistent AF requiring repeat treatments,seven the need for more precise therapies is important.

About the TAILORED-AF trial
TAILORED-AF is an international, multi-center trial designed to determine whether a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a strategy of conventional anatomical ablation targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes> 30 seconds, with or without anti-arrhythmic drugs (DAAs), 12 months after a single index ablation procedure. Secondary endpoints include freedom from episodes of AF and / or atrial tachycardia (AT) after 12 months, after one or more procedures, as well as safety. Volta Medical is awaiting the results of the TAILORED-AF trial in 2024.

For more information on participating in the TAILORED-AF trial, contact Dan Guerrero [email protected]

About Volta Medical
Volta Medical is a healthcare technology company that develops AI software solutions to help cardiac electrophysiologists in the operating room. Volta’s overall goal is to dramatically improve cardiac arrhythmia management by developing state-of-the-art medical devices based on large procedural databases with the highest standards of data protection. Founded by three doctors and a data scientist in 2016 in Marseille, France, Volta’s first product, VX1, helps cardiologists identify specific abnormal electrograms, called scatter electrograms, in real time. For more information, visit the company’s website at www.volta-medical.com.

Media contacts United States

Glenn silver
Lazar-FINN Partners
[email protected]
(973) 818-8198

The references

1https://kompetenznetz-vorhofflimmern.de/en [last accessed Aug 9, 2021]

3Chugh SS et al. Global burden of atrial fibrillation in developed and developing countries. Global heart. 2014; 9 (1): 113-9. DOI: https://doi.org/10.1016/j.gheart.2014.01.004

4January CT, Wann LS, Alpert JS, et al. 2014 AHA / ACC / HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology / American Heart Association Task Force on Practice Guidelines and of the Heart Rhythm Society. J Am Coll Cardiol 2014 ; 64: 2246-2280. DOI: https://www.ahajournals.org/doi/10.1161/cir.00000000000000040

5Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of the current and future incidence and prevalence of atrial fibrillation in the US adult population. Am J Cardiol 2013; 112: 1142-1147. DO I: 10.1016 / j.amjcard.2013.05.063

6The working group for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC). ESC 2020 guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal (2020) 42, 373498. DOI: https://doi.org/10.1093/eurheartj/ehaa612

sevenTutuianu C. et al. The very long term results of atrial fibrillation ablation confirm that this therapy is truly effective. J Atr Fibrillation. 2015 August-September; 8 (2): 1226. DOI: https://doi.org/10.4022/jafib.1226