St. Jude Medical (NYSE:STJ) today said the FDA approved its bendable-tip FlexAbility ablation catheter for treating cardiac fibrillation.
St. Paul, Minn.-based St. Jude said the new device’s bendable, irrigated tip is designed to ease access to the inside of the heart and increase maneuverability in complex cases.
"As we developed the FlexAbility ablation catheter, we worked with leading electrophysiologists to ensure this ablation technology would advance the treatment of complex arrhythmias," clinical, medical & scientific affairs vice president Dr. Srijoy Mahapatra said in prepared remarks. "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 within Europe has confirmed that we have met this goal and the FlexAbility catheter is well positioned to become an important ablation technology for electrophysiologists around the world."
The FlexAbility catheter won CE Mark approval in the European Union last summer. Its stable-mate, the TactiCath Quartz St. Jude acquired in 2013 with the $331 million EndoSense buy, has been on the market in Europe since 2012 and won an FDA nod last year.
“The FlexAbility catheter is the only ablation catheter with a flexible tip available to electrophysiologists in the United States today," Dr. Andrea Natale of Austin’s Texas Cardiac Arrhythmia Institute said in a statement. "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."