FDA News

FDA approves software for use during ablation in AF

Johnson & Johnson Medical Devices Companies announced that Biosense Webster received approval from the FDA for a novel Tag Index guided software for the treatment of patients with paroxysmal atrial fibrillation.

The software (Visitag Surpoint External Processing Unit, Biosense Webster) is to be used during a catheter ablation procedure to calculate a Tag Index, according to a press release from the company. The Tag Index combines parameters of contact force, power and duration during an ablation procedure, which can standardize and simplify workflow while aiding electrophysiologists using a technology (Carto Smarttouch, Biosense Webster) to achieve pulmonary vein isolation.

The software has been used outside of the U.S. to treat over 30,000 patients, according to the release.

A post-market approval study is currently enrolling and treating patients to assess Tag Index-guided ablation with the software.

“We’re always looking for ways to improve procedure efficiency and are proud to be early adopters of this innovative technology,” Jose Osorio, MD, medical director of the Atrial Fibrillation Clinic and Cardiac Electrophysiology Program at Grandview Medical Center in Birmingham, Alabama, said in the press release. “I look forward to integrating the prescriptive Tag Index guided ablation into my workflow for [pulmonary vein isolation].”

Disclosure: Osorio reports he is a consultant for Biosense Webster.

Johnson & Johnson Medical Devices Companies announced that Biosense Webster received approval from the FDA for a novel Tag Index guided software for the treatment of patients with paroxysmal atrial fibrillation.

The software (Visitag Surpoint External Processing Unit, Biosense Webster) is to be used during a catheter ablation procedure to calculate a Tag Index, according to a press release from the company. The Tag Index combines parameters of contact force, power and duration during an ablation procedure, which can standardize and simplify workflow while aiding electrophysiologists using a technology (Carto Smarttouch, Biosense Webster) to achieve pulmonary vein isolation.

The software has been used outside of the U.S. to treat over 30,000 patients, according to the release.

A post-market approval study is currently enrolling and treating patients to assess Tag Index-guided ablation with the software.

“We’re always looking for ways to improve procedure efficiency and are proud to be early adopters of this innovative technology,” Jose Osorio, MD, medical director of the Atrial Fibrillation Clinic and Cardiac Electrophysiology Program at Grandview Medical Center in Birmingham, Alabama, said in the press release. “I look forward to integrating the prescriptive Tag Index guided ablation into my workflow for [pulmonary vein isolation].”

Disclosure: Osorio reports he is a consultant for Biosense Webster.