Volta Medical issued the following announcement on Dec. 9.
Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AFib) or atrial tachycardia. These annotations help physicians locate heart regions harboring a specific electrogram abnormality, known as spatiotemporal dispersion. This innovative detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to either burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways.
According to Seth H. Goldbarg, MD, FACC, FHRS, Director of Cardiac Electrophysiology, New York Presbyterian/Queens, Assistant Professor, Weill Cornell Medical College, Flushing, NY, USA, "AFib represents a major challenge in cardiology due to the complexities associated with identification, localization and treatment of the pathological zones that cause and perpetuate this abnormal heart rhythm. The current standard of care does not provide us with a uniform, easy to follow and predictable approach to identify these regions. This has led to heterogenous approaches to treating these patients, with very mixed and often disappointing results. We are excited to be part of the further studies taking place with this AI software, as the VOLTA system may provide a major step forward in the effective approach to ablation of persistent AFib."
Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise in persistent AFib patients than desired. Their results, even if significant in certain cases, remain sub-optimal. Localization and ablation of drivers perpetuating AFib has been at the forefront of cardiovascular disease research but has not led to any radical changes to-date. The Volta mapping system is intuitive, user-friendly and shows promise to potentially reduce inter-operator variability in the analysis of procedural data without lengthening either the diagnostic or therapeutic procedures.
The VX1 system holds enormous promise for offering an easier, faster, more accurate and reliable way to identify zones of interest in patients who suffer from chaotic heart muscle contractions. Developed jointly by top experts in the fields of electrophysiology and digital technologies, VX1 is simple to use. It bears the potential to provide a permanent solution to a chronic health burden with a one-time breakthrough procedure and has the potential to become the gold standard AI solution, for efficient and affordable cardiac ablation procedures. For Jérôme Kalifa, MD and cofounder of Volta Medical, "Our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms. This is what is generating increasing enthusiasm around the potential of our solution. The recently obtained FDA clearance is an important milestone for our company and ultimately for patients who suffer from difficult to treat forms of AFib."
About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a HealthTech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta's overarching goal is to drastically improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data with the highest standards of data protection. Its first product, VX1, assists cardiologists for 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 the VX1 AI software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and technologies currently used in operating rooms or electrophysiology labs. The VX1 software analyzes the patient's electrograms in real-time to identify specific electrograms known as dispersed electrograms. It also provides a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations. VX1 is a medical device which is FDA cleared and has a CE mark.
About atrial fibrillation (AFib or AF)
AFib can be considered an "electrical storm" in the atria in which all synchronized activities have disappeared, and the necessary coordination of the contraction stops. This can lead to a number of symptoms including palpitations, shortness of breath, and in some patients, heart failure. AFib is also a major risk factor for stroke, as stagnant blood in the atrium during AFib may lead to the formation of a clot, that can migrate to the brain. This is why AFib is such an important risk factor for heart failure and stroke and a major reason for loss of quality life.
AFib is expected to reach 12.1 million patients in the US by 2030. Prevalence of arrhythmias increases with age and total annual costs for treatment of AFib in the US were estimated already in 2001 at US$6.65 billion. Evidence suggests a higher prevalence of AFib in patients with hypertension, heart failure, coronary heart disease, obesity and diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AFib before, during or after the initial event. AFib increases the likelihood of stroke by four to five times while AFib-induced strokes are generally associated with more severe damage
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