Technology | May 23, 2016

Boston Scientific Announces FDA Approval of Navigation-Enabled Ablation Catheters

New catheters and software enhancement expand capabilities of high-definition Rhythmia Mapping System

Boston Scientific, FDA, IntelliNav XP ablation catheters, Rhythmia Mapping System

Rhythmia Mapping System image courtesy of Boston Scientific


May 23, 2016 — Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for two catheters that can be used with the Rhythmia Mapping System. The IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters – designed to map and ablate – were approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. These are the first magnetically-tracked catheters that Boston Scientific will offer to the U.S. market. Along with the immediate launch of the catheters, the company is also releasing a software enhancement for the Rhythmia Mapping System.

Unlike conventional cardiac mapping systems, the Rhythmia Mapping System rapidly and automatically generates three-dimensional images of any chamber of the heart to help diagnose, locate and treat the source of rhythm abnormality. The Software Version 1.4 mapping system update improves the speed and quality in which the images are acquired using a variety of therapeutic and diagnostic catheters, including the IntellaNav XP and IntellaNav MiFi XP catheters. The software update also provides advanced editing capabilities, allowing for detailed visual enhancements of the maps.

Both of the newly approved IntellaNav XP catheters feature magnetic sensors which track the location of the catheter while delivering radiofrequency energy into the heart muscle, creating heat to destroy a small area of the tissue responsible for the abnormal heart rhythm.

The IntellaNav MiFi XP catheter also provides increased accuracy and signal clarity via mini-electrode technology, which delivers a highly localized signal closely reflecting what is happening at the tip in real-time during the ablation procedure.

For more information: www.bostonscientific.com


Related Content

News

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

Home October 30, 2024
Home
News

Oct. 18, 2024 — Boston Scientific Corp. recently announced it has received U.S. Food and Drug Administration (FDA) ...

Home October 21, 2024
Home
News

May 15, 2024 —CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac ...

Home May 15, 2024
Home
News

May 13, 2024 — Innovative Health, Inc. announced that recent growth in single-use device reprocessing has delivered ...

Home May 13, 2024
Home
News

October 10, 2023 — Axon Therapies, a private company focused on addressing a root cause of heart failure, announced 6 ...

Home October 10, 2023
Home
News

August 9, 2023 — Boston Scientific Corporation announced it has received U.S. Food and Drug Administration (FDA) ...

Home August 09, 2023
Home
News

January 31, 2023 —Imricor, a global leader in real-time interventional cardiac magnetic resonance (iCMR) ablation ...

Home January 31, 2023
Home
News

December 21, 2022 — Stereotaxis, a global leader in robotic technologies for the treatment of cardiac arrhythmias ...

Home December 21, 2022
Home
News

October 24, 2022 — Acutus Medical, Inc, an arrhythmia management company focused on improving the way cardiac ...

Home October 24, 2022
Home
News

May 13, 2022 — Acutus Medical, an arrhythmia management company focused on improving the way cardiac arrhythmias are ...

Home May 13, 2022
Home
Subscribe Now