CE Mark and First Use of St. Jude’s FlexAbility™ Ablation Catheter

St. Jude Medical, Inc. has gained CE Mark approval and announced first use of the FlexAbility™ Ablation Catheter, a novel ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias.

Background

Worldwide, an estimated 34 million individuals have atrial fibrillation (AF), the most common type of arrhythmia. The gold standard treatment involves the use of an ablation catheter such as St. Jude’s FlexAbility. St. Jude’s press release points to the FlexAbility catheter’s key features including an innovative handle and shaft that allows for improved maneuverability, enabling electrophysiologists 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.

Designed with feedback from physician thought-leaders 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 approval of the FlexAbility catheter further strengthens St. Jude Medical’s fast-growing ablation technology portfolio, which also includes the TactiCath™ contact-force sensing irrigated ablation catheter covered on our pages here.

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.

Physician comments

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

Company comments

“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 electrophysiologists across the wide spectrum of patient anatomies.”

Source: St. Jude Medical, Inc., Business Wire

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