Volta Medical has announced that it has obtained US Food and Drug Administration (FDA) clearance for its VX1 AI (artificial intelligence) software. According to Volta, 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 (AF) or atrial tachycardia. These annotations help physicians locate heart regions harbouring a specific electrogram abnormality, known as spatiotemporal dispersion. This detection and patient-specific localisation of abnormal regions may eventually help physicians better decide where they need to intervene using radiofrequency or cryotherapy.
According to Seth H Goldbarg, director of cardiac electrophysiology, New York Presbyterian/Queens, assistant professor, Weill Cornell Medical College, New York, USA, “AF represents a major challenge in cardiology due to the complexities associated with identification, localisation 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 AF.”
Jérôme Kalifa cofounder of Volta Medical, said ”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 AF.”