
European regulators put their stamp of approval on St. Jude Medical’s (NYSE:STJ) new FlexAbility ablation catheter, paving the way to 1st use of the next-generation device.
The 1st post-approval surgeries took place at hospitals in Portugal and France, where doctors used FlexAbility to help treat irregular heart rhythms. St. Jude estimated that some 34 million patients worldwide are affected by atrial fibrillation, the most common type of irregular heartbeat.
The FlexAbility system helps doctors maneuver to hard-to-reach areas of the anatomy to form lesions and knock out problem muscles believed to contribute to erratic heart rhythms. The device also gathers electrical data from the heart, which is displayed on the EnSite Velocity cardiac mapping and navigation system.
"The FlexAbility catheter brings technical and functional advancements to the electrophysiology lab through its unique catheter tip and excellent handling capabilities," Dr. Andrea Natale, who performed the 1st FlexAbility procedure in Portugal, said on behalf of the company. "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."
FlexAbility joins St. Jude’s portfolio of CE Marked ablation technologies, which includes the TactiCath contact-force sensing ablation catheter that St. Jude nabbed last year in the $331 million acquisition of Swiss device maker Endosense.
STJ shares remained pretty flat today, trading at a 0.5% increase of $67.38 as of about 12 p.m. EST. The stock has gained 8.8% since the start of the year.