FDA approves St Jude Medical’s FlexAbility Ablation Catheter

28 January 2015 (Last Updated January 28th, 2015 18:30)

US Food and Drug Administration (FDA) has granted approval for St Jude Medical's FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists to treat cardiac arrhythmias.

Tip

US Food and Drug Administration (FDA) has granted approval for St Jude Medical's FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists to treat cardiac arrhythmias.

The catheter combines a bendable irrigated catheter tip with an advanced handle and next-generation shaft design, allowing effective lesion formation.

Texas Cardiac Arrhythmia Institute executive medical director Dr Andrea Natale said: "The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today.

"For the past several years we've been looking for a catheter that provided a gentler, more optimal approach to ablation.

"The FlexAbility catheter addresses this need and provides me with another safe treatment option for my patients."

"The catheter combines a bendable irrigated catheter tip with an advanced handle and next-generation shaft design, allowing effective lesion formation."

The company said that ablation catheters such as FlexAbility catheter, are thin and flexible wires used to treat irregular heartbeats that impair the heart's ability to effectively pump blood throughout the body.

The new ablation technology will also help to provide optimal irrigation flow over the entire tip for improved cooling, and reduce risk factors associated with the delivery of therapy.

St Jude Medical clinical, medical and scientific affairs vice-president Srijoy Mahapatra said: "As we developed the FlexAbility ablation catheter, we worked with leading electrophysiologists to ensure this ablation technology would advance the treatment of complex arrhythmias.

"Our development goal was to leverage the unique flexible tip and combine it with optimal performance and maneuverability, especially during the most challenging clinical cases."

The company secured CE Mark approval for FlexAbility catheter in 2013.

TactiCath Quartz contact-force sensing irrigated ablation catheter was approved and made commercially available in Europe since 2012 and the US since 2014, to treat paroxysmal atrial fibrillation (AF).


Image: Flexible tip of the St Jude Medical's FlexAbility ablation catheter. Photo: courtesy of St Jude Medical.