VIVO system cleared by FDA
June 27, 2019
MT. OLIVE, N.J., June 26, 2019 /PRNewswire/ -- Catheter Precision, Inc., announced today that the U.S. Food and Drug Administration (FDA) has cleared its new VIVO™ (View into Ventricular Onset) system for market release in the United States. VIVO is a pre-procedure planning tool that offers 3D cardiac mapping to aid in localizing the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to electrophysiology studies. The novel VIVO system uses magnetic resonance imaging (MRI) or a computed tomography (CT) scan along with a standard 12-lead ΕCG to computer-generate color-coded 3D mapping images of the heart to indicate the area of earliest activation.
"The FDA clearance of the VIVO system puts an important new tool in the hands of electrophysiologists that allows for highly accurate, non-invasive identification of ventricular arrhythmia origins, displayed on a colorized 3D map," said Steve Adler, Chief Executive Officer of Catheter Precision. "VIVO uses a proprietary algorithm based on proven electrophysiology principles to generate an accurate 3D model of the heart with a superimposed electrical activation map. These 3D maps help physicians pinpoint the sites of origin for certain types of rhythm disorders. It's a major advance in cardiac electrophysiology, plus it is a significant milestone in the history of Catheter Precision."
The VIVO system consists of a hand-held 3D camera, and an off-the-shelf laptop computer with proprietary software. Using a 3D photograph of the patient's chest, an MRI or CT (DICOM image), and a standard 12-lead ECG, the system generates a 3D rendering of the patient's heart with superimposed color coding to indicate the area of earliest activation. VIVO uses lead positions, the chest photograph, and DICOM data to determine the precise spatial relationships involved and, in that way, provide latest-generation cardiac mapping that can be used by a physician prior to conducting an electrophysiology study and subsequent ablation. The accuracy of the VIVO system has been shown to be 100% accurate (95% CI: 93.6%, 100%) in a prospective multi-center clinical trial.
"VIVO is an important advance for patients who may require a cardiac ablation to better understand their irregular heart rhythms," said Hari Tandri, MD from Johns Hopkins University Hospital. "It is easy to use, fits into our standard workflow and is not invasive. Knowing the arrythmia foci in advance should reduce mapping time, potentially saving procedure time and cost. My experience with the VIVO to date has shown it to be an accurate, easy-to-use system that has the potential to significantly improve 3D cardiac mapping technology for ventricular arrhythmia mapping."
Catheter Precision is focused on electrophysiology to develop novel technologies that will provide patients, physicians, and hospitals with new tools to improve the lives of people suffering from cardiac arrhythmias. With offices in the United States and Europe, Catheter Precision makes its innovative devices available worldwide.
SOURCE Catheter Precision, Inc.