Volta Medical, a pioneering health tech company developing artificial intelligence (AI)-based software solutions to treat cardiac arrythmias, today announced the introduction of its leading-edge product, VX1, at three leading U.S. hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital in New York City, and Ascension St. Vincent’s Riverside, Jacksonville, FL, are the first U.S. hospitals to implement VX1, which is designed to improve outcomes for patients undergoing atrial fibrillation (AF) ablation procedures.
All three hospitals also are recruiting AF ablation patients to participate in an international, randomized controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation called TAILORED-AF trial. The international, multi-center trial will involve 25 sites and 342 patients and is expected to report results in 2024. VX1 is cleared as a medical device by the U.S. Food and Drug Administration and CE-certified by the European Union.
VX1 is the first commercially available AI software to help clinicians combat high failure rates in the use of ablation for treating persistent, drug-resistant AF. AF, characterized by an irregular and chaotic heartbeat (cardiac arrythmia), can lead to more serious health issues such as heart failure and stroke. During AF ablation, a specialized cardiologist known as an electrophysiologist inserts catheters through the blood vessels into the heart to burn or freeze tissue that is causing abnormal electrical signals in the upper chamber, or atrium. The procedure creates scarring that restores a normal heartbeat.
The VX1 system analyzes electrical signals measured during the procedure and identifies abnormalities in real-time. VX1 is versatile and can be installed in most operating rooms and is compatible with the main multipolar catheters and mapping systems.
About atrial fibrillation (AFib or AF)
An estimated 6.1 million people in the United States have AF with projections to reach nearly 12.1 million in 2030. Worldwide, it affects more than 33 million people. Symptoms include palpitations, lightheadedness and shortness of breath. In some patients, AF can lead to heart failure. AF is not only an extremely costly public health issue but also a major risk factor for stroke, posing a 4-to-5 times greater risk than for the general population. AF is commonly treated with medication that regulates or slows the heart rate. For patients who cannot tolerate or are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care. Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heartbeat. However, the efficacy of this approach depends largely on the experience and intuition of the electrophysiologist. With 50% of persistent AF patients requiring repeat treatments, the need for more precise therapies is significant.
About the TAILORED-AF trial
TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy 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 (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024.
About Volta Medical
Volta Medical is a health tech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta’s overarching goal is to significantly improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices based on large databases of procedural data with the highest standards of data protection. Founded by three physicians and a data scientist in 2016 in Marseille, France, Volta’s first product, VX1, assists cardiologists in the real-time identification of specific abnormal electrograms, known as dispersed electrograms. For more information, visit the company’s website at www.volta-medical.com.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor with two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in fast growing, innovative companies active in (bio)pharmaceuticals, healthtech and medtech that are based in Europe and North America. For more information, please visit: www.gildehealthcare.com.