St Jude Medical announces FDA approval of FlexAbility Ablation Catheter


St Jude Medical has received US Food and Drug Administration (FDA) approval of the FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias.

According to a company release, the FlexAbility catheter was designed with feedback from leaders in the electrophysiology community. FlexAbility combines a bendable irrigated catheter tip with an advanced handle and “next-generation” shaft design. The flexible tip was developed to better conform to the cardiac anatomy, allowing for effective lesion formation.

“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the USA today,” says Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute, USA. “For the past several years we have 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.”

St Jude medical says that the FlexAbility catheter features a handle and shaft combination that allows for improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients’ hearts. This new technology was also designed to provide optimal irrigation flow over the entire tip for improved cooling, potentially reducing risk factors associated with the delivery of therapy.

“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. Physician experience in Europe has confirmed that we have met this goal,” says Srijoy Mahapatra, vice president of clinical, medical and scientific affairs at St Jude Medical.