St. Jude Medical, a global medical device manufacturer, has obtained CE Mark approval for its FlexAbility ablation catheter for the treatment of cardiac arrhythmias.


The company has also announced the first use of the FlexAbility ablation catheter, which combines an irrigated flexible catheter tip with an innovative handle and catheter design.

The first cases that used the FlexAbility catheter, post-approval, took place at IdealMed Unidade Hospitalar de Coimbra in Portugal and at the Hopital Haut-Leveque in France.

According to the company, the next-generation flexible tip technology reduces 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.

St. Jude Medical group president Eric Fain said: "The goal of the FlexAbility catheter was to bring the most advanced irrigated ablation solution to the electrophysiology market.

"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."

Featuring a handle and shaft, the FlexAbility catheter provides improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients.

The company has designed the technology to provide optimal irrigation flow over the entire tip for improved cooling, reducing risk factors associated with the delivery of therapy.

EnSite Velocity system, a cardiac mapping and navigation system, records electrical information from the heart once FlexAbility catheters are inserted in the cardiac chamber and displays the data in a three-dimensional anatomical model.

Physicians can diagnose and guide treatment for abnormal heart rhythms with the help of highly detailed anatomical models, or maps.

Image: European approval of FlexAbility ablation catheter further strengthens St. Jude Medical’s fast-growing ablation technology portfolio. Photo: Courtesy of Business Wire