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:

Related Content

Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems | December 08, 2017
December 7, 2017 — Stereotaxis Inc.
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems | October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems | October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems | August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems | July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems | May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems | May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems | February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems | January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems | November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Overlay Init