St. Jude Gains CE Mark for Flexability Ablation Catheter

St. Paul, Minn.-based medical device powerhouse St. Jude Medical Inc. has been granted CE mark for its Flexability ablation catheter, an ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Designed with feedback from physician thought-leaders around the world, the Flexability catheter combines an 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 electrophysiologists across the wide spectrum of patient anatomies.”

Ablation catheters, such as the Flexability irrigated ablation catheter, are thin, flexible wires used to help treat irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. 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 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. The first cases that used the Flexability catheter post-approval took place at IdealMed Unidade Hospitalar de Coimbra in Coimbra, Portugal by Andrea Natale, M.D., and at the Hôpital Haut-Lévèque in Bordeaux, France by Nicolas Derval, M.D.

“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 electrophysiologists 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 three-dimensional anatomical model. The highly detailed anatomical models, or maps, are meant to enable physicians to diagnose and guide treatment for abnormal heart rhythms.

St. Jude Medical’s ablation technology portfolio also includes the Tacticath contact-force sensing irrigated ablation catheter, which was approved and has been commercially available in Europe since 2012. The catheter is designed to give physicians a real-time, objective measure of the force applied to the heart wall during a cardiac ablation procedure. Both the Tacticath and Flexability ablation catheters are investigational devices in the United States.