News | July 30, 2014

St. Jude Medical’s FlexAbility Ablation Catheter Receives CE Mark Approval

July 30, 2014 — St. Jude Medical announced CE mark approval and first use of the FlexAbility ablation catheter, a novel ablation technology used by electrophysiologists (EPs) for the treatment of cardiac arrhythmias. Designed with feedback from physicians around the world, the FlexAbility catheter combines a unique, irrigated flexible catheter tip with a state-of-the-art handle and catheter design. The next-generation flexible tip technology was designed to reduce complications associated with ablation procedures through its ability to bend and conform to the cardiac anatomy, decreasing the amount of pressure distributed to a patient’s heart wall while simultaneously increasing the stability of therapy delivery.

“The goal of the FlexAbility catheter was to bring the most advanced irrigated ablation solution to the electrophysiology market,” said Eric S. Fain, M.D., group president at St. Jude Medical. “Because we worked with industry thought leaders throughout the development of this technology, we are confident that its completely redesigned handle and shaft, along with its unique flexible tip, will become a leading ablation technology that addresses the broad needs of EPs across the wide spectrum of patient anatomies.”

Worldwide, an estimated 34 million individuals have atrial fibrillation (AF), the most common type of arrhythmia. The FlexAbility catheter features an innovative handle and shaft that allows for improved maneuverability, enabling EPs to reach challenging anatomic locations within their patients. The technology was designed to provide optimal irrigation flow over the entire tip for improved cooling, reducing risk factors associated with the delivery of therapy. The first cases that used the FlexAbility catheter post-approval took place at IdealMed Unidade Hospitalar de Coimbra in Coimbra, Portugal, by Dr. Andrea Natale and at the Hôpital Haut-Lévèque in Bordeaux, France, by Dr. Nicolas Derval.

“The FlexAbility catheter brings technical and functional advancements to the electrophysiology lab through its unique catheter tip and excellent handling capabilities,” said Natale. “The catheter tip allows for effective lesion formation with potentially fewer risks, representing an important option for EPs that are looking to broaden their ability to treat arrhythmias with increased confidence.”

Data that are produced by the FlexAbility ablation catheter are displayed on the EnSite Velocity system, a cardiac mapping and navigation system. Once FlexAbility catheters are inserted in the cardiac chamber, the EnSite system records electrical information from the heart and displays it in a 3-D anatomical model. The highly detailed anatomical models, or maps, enable physicians to diagnose and guide treatment for abnormal heart rhythms.

The FlexAbility ablation catheter is an investigational device in the United States.

For more information: www.sjm.com

Related Content

Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Imricor MRI-Guided Cardiac Ablation Study Results to Be Presented at HRS 2018
News | Ablation Systems | May 10, 2018
Results from the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter...
Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath
Technology | Ablation Systems | May 08, 2018
Biosense Webster Inc. announced its Carto Vizigo Bi-directional Guiding Sheath is now available in the United States....
Stereotaxis and Acutus Medical Announce Strategic Collaboration
News | Ablation Systems | May 04, 2018
Stereotaxis and Acutus Medical announced a strategic collaboration to integrate the Stereotaxis Niobe Magnetic...
Medtronic Cryoballoon Shows Positive Results for Patients With Persistent Atrial Fibrillation
News | Ablation Systems | April 12, 2018
Medtronic plc announced one-year results from the CRYO4PERSISTENT AF study of ablation with the Arctic Front Advance...
Overlay Init