Johnson & Johnson have announced that Biosense Webster has received approval from the US Food and Drug Administration (FDA) for its VISITAG SURPOINT External Processing Unit and enrolment has begun in its post-market approval study.
The VISITAG SURPOINT Module calculates a Tag Index, a single value combining parameters of power, contact force and duration during a catheter ablation procedure. The index was developed to simplify and standardise the workflow for ablating patients with paroxysmal atrial fibrillation (PAF) and to support electrophysiologists using the CARTO SMARTTOUCH Technology, to achieve Pulmonary Vein Isolation (PVI).
At Grandview Medical Center in Birmingham, USA, Jose Osorio recently enrolled and treated the first patients in a post-market approval study that is assessing Tag Index-guided ablation using the VISITAG SURPOINT Module.
“We’re always looking for ways to improve procedure efficiency and are proud to be early adopters of this innovative technology,” said Osorio, board certified cardiac electrophysiology and cardiovascular disease, Grandview Medical Center, Birmingham, USA. “I look forward to integrating the prescriptive Tag-Index guided ablation into my workflow for PVI.”
Over 30,000 patients have been treated with the technology outside the US, where it is commercialised as CARTO 3 System CARTO VISITAG Module with Ablation Index.
“Biosense Webster is committed to developing technologies, techniques and tools that optimise procedures and advance the treatment of atrial fibrillation,” said Celine Martin, worldwide president of Biosense Webster. “Beginning commercialisation of the VISITAG SURPOINT Module in the US is a major milestone.”
An estimated 33 million people worldwide have been diagnosed with atrial fibrillation and its prevalence is projected to increase significantly as the population ages. Approximately 70% of patients with atrial fibrillation are between the ages of 65 and 85.