Tuesday, March 31, 2020

Tuesday, March 31, 2020

VIVO System cleared by FDA

The VIVO (View Into Ventricular Onset) system from Catheter Precision has been cleared by the Food and Drug Administration for market release in the U.S.

This tool uses 3D cardiac mapping to find where idiopathic ventricular arrhythmias began in patients, and MRI or CT scan in conjunction with ECG to map the heart.

“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.”

In a prospective multi-center clinical trial, the VIVO system was 100 percent accurate at finding the origin of the arrythmias.

“VIVO is an important advance for patients who may require a cardiac ablation to better understand their irregular heart rhythms,“ said Hari Tandri 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.”

Organizations in this Story

US Food and Drug Administration

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