Catheter Precision Inc. asserted the launch of a pivotal Clinical Trial to evaluate the safety and accuracy of the VIVO Non-Invasive Mapping system. The VIVO system is designed to provide pre-procedure guidance to the cardiologist by identifying the area of the heart where the abnormal rhythm initiates.
The ability to target the area of arrhythmia onset should minimize the need for multi-hour invasive mapping prior to the ablation procedure, ultimately reducing overall procedure time. The first study subjects have been enrolled at the University of Iowa Hospitals and Clinics and Johns Hopkins University School of Medicine. Arrhythmias or irregular heart rhythms affect millions of Americans and certain types are potentially life threatening; some arrhythmias can be effectively treated with ablation. During ablation, a small area of the cardiac tissue associated with the arrhythmia is scarred or destroyed so it can no longer send out the electrical signals causing the arrhythmia.
Steve Adler, President and CEO of Catheter Precision Inc said “We are pleased to be working with the physicians at these prestigious institutions on this study. Identification of the location where arrhythmic signals originate can take several hours. Reducing the time to ablation should reduce the time it takes the physician to successfully treat cardiac arrhythmias.”
The VIVO system is a software product that includes a laptop computer and 3D camera. Using non-invasive clinical inputs (12-lead ECG, cardiac magnetic resonance image or computed tomography) and a 3D image of the patient’s torso, VIVO combines patient-specific images (MRI or CT) of the torso and cardiac structures and a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient’s heart with a superimposed activation map.