Technology | October 09, 2018

FDA Approves Biosense Webster's Tag-Index Guided Ablation Software

First patients concurrently enrolled in atrial fibrillation PMA study

FDA Approves Biosense Webster's Tag-Index Guided Ablation Software

October 9, 2018 — Biosense Webster Inc. recently received approval from the U.S. Food and Drug Administration (FDA) for its Visitag Surpoint External Processing Unit, and enrollment 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 standardize 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).

Jose Osorio, M.D., at Grandview Medical Center in Birmingham, Ala., 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. “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 U.S, where it is commercialized as CARTO 3 System CARTO VISITAG Module with Ablation Index.

An estimated 33 million people worldwide have been diagnosed with atrial fibrillation and its prevalence is projected to increase significantly as the population ages.[1]  Approximately 70 percent of patients with atrial fibrillation are between the ages of 65 and 85.[2]

For more information: www.biosensewebster.com

 

References

[1] European Heart Journal, Volume 37, Issue 38, 7 October 2016, Pages 2893–2962, https://doi.org/10.1093/eurheartj/ehw210

[2] Amin A, Houmsse A, Ishola A, Tyler J, Houmsse M. The current approach of atrial fibrillation management. Avicenna J Med. 2016 Jan-Mar; 6(1): 8–16.

 


Related Content

News

Oct. 10, 2025 — Johnson & Johnson MedTech, in collaboration with the Heart Rhythm Clinical and Research Solutions, LLC ...

Home October 13, 2025
Home
News

Sept. 2, 2025 — Johnson & Johnson MedTech has announced acute safety and effectiveness results from the Varipure ...

Home September 05, 2025
Home
News

Sept. 3, 2025 — Kardium Inc. recently announced it has received pre-market approval (PMA) for the Globe Pulsed Field ...

Home September 03, 2025
Home
News

July 14, 2025  –  Johnson & Johnson MedTech has announced U.S. Food and Drug Administration (FDA) approval of an update ...

Home July 14, 2025
Home
News

July 7, 2025 — Catheter ablation is a minimally invasive treatment for abnormal heart rhythms. It is often successful in ...

Home July 09, 2025
Home
News

June 4, 2025 — A new study published in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons ...

Home June 04, 2025
Home
News

April 24, 2025 – The Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) have released a scientific ...

Home April 24, 2025
Home
News

April 9, 2025 — Merit Medical Systems has announced the U.S. commercial release of its Ventrax Delivery System. Ventrax ...

Home April 16, 2025
Home
News

March 27, 2025 — Abbott recently announced it has received CE Mark in Europe for the Volt PFA System to treat patients ...

Home March 27, 2025
Home
News

Oct. 24, 2024 — Medtronic plc has announced United States Food and Drug Administration (FDA) approval of the Affera ...

Home October 30, 2024
Home
Subscribe Now