FDA Gives Nod to New Flexible Ablation Catheter from St. Jude
The FDA has awarded premarket approval to St. Jude Medicals’ FlexAbility ablation catheter, offering physicians a means of more easily reaching challenging locations in the heart, the company said Tuesday. The FlexAbility is now available and ready to ship, the devicemaker added.
The system includes a bendable irrigated catheter tip, designed to better conform to the heart’s anatomy, and an advanced handle and next-generation shaft design.
Ablation catheters are used to help treat irregular heartbeats, which impair the heart’s ability to pump blood. FlexAbility optimizes irrigation of the catheter tip, for improved cooling and lower patient risk, the company said.
Srijoy Mahapatra, vice president of clinical, medical and scientific affairs at St. Jude, said the company worked with electrophysiologists to ensure that the technology will advance treatment of complex arrhythmias. Physician use in Europe has confirmed that the company met this goal, he added.
An estimated 10.4 million Americans have some form of cardiac arrhythmia, St. Jude said. The catheter was CE-marked last year. — Kellen Owings