FDA Approves First Flexible-Tipped Cardiac Ablation Catheter

Last July, St. Jude Medical, Inc. gained CE mark approval for its FlexAbility™ Ablation Catheter. Now the medtech titan has announced U.S. FDA approval of the device, flexible tipped ablation device for the treatment of cardiac arrhythmias.


Ablation catheters are thin, flexible wires used to help treat irregular heartbeats, so-called arrhythmias, that impair the heart’s ability to effectively pump blood throughout the body. St. Jude’s new device promises to move the game forward, offering as it does the only flexible tip design available in the U.S. This feature was developed to allow better conformance to the cardiac anatomy, with the consequent potential to optimize delivery of therapeutic ablation to the heart wall.

The FlexAbility catheter also features an innovative handle and shaft combination that leads to claims of improved maneuverability, enabling electrophysiologists to reach challenging anatomic locations within their patients’ hearts. St. Jude says 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.

The FlexAbility ablation catheter was developed to be used seamlessly with St. Jude Medical’s existing portfolio of electrophysiology products, including the EnSite™ Velocity™ System, the Ampere™ RF Generator and the Agilis™ NxT Steerable Introducer.

St. Jude says the FDA approval of the FlexAbility catheter further strengthens its fast-growing ablation technology portfolio and expands the ability of physicians to treat patients battling abnormal heart rhythms.

Physician comments

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

Company comments

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

Source: Business Wire


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