St. Jude Medical Announces FDA Approval of FlexAbility Ablation Catheter

Approval introduces the first and only irrigated ablation catheter with a flexible tip in the U.S., adding to the company’s unrivaled ablation technology portfolio

ST. PAUL, Minn.-- St. Jude Medical, Inc., a global medical device company, today announced U.S. Food and Drug Administration(FDA) approval of the FlexAbility™ Ablation Catheter, a new ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Designed with feedback from leaders in the electrophysiology community, the FlexAbility catheter combines a bendable irrigated catheter tip with an advanced handle and next generation shaft design. The unique flexible tip was developed to conform better to the cardiac anatomy, allowing for effective lesion formation. This added flexibility, in addition to the catheter’s ability to maneuver easily and reliably in challenging cases, was designed to enhance the quality of care for patients around the world who require ablation procedures.

“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.”

Ablation catheters, such as the pioneering FlexAbility catheter, are thin, flexible wires used to help treat irregular heartbeats that impair the heart’s ability to effectively pump blood throughout the body. In the U.S., an estimated 10.4 million people have some type of cardiac arrhythmia. The FlexAbility catheter features an innovative 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.

“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 withinEurope 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 FDA approval of the FlexAbility catheter, which received CE Mark in Europe last year, further strengthens St. Jude Medical’s fast-growing ablation technology portfolio and expands the ability of physicians to treat patients battling abnormal heart rhythms. The TactiCath™ Quartz contact-force sensing irrigated ablation catheter, approved and commercially available in Europe since 2012 and the U.S. since 2014, pioneered the ability to give physicians a real-time, objective measure of the force applied to the heart wall during a cardiac ablation procedure to treat paroxysmal atrial fibrillation (AF). The introduction of the FlexAbility catheter in the U.S. provides physicians with a best in class catheter for all their non-contact force cases. Combined, the technology offers physicians two new unique catheters that offer innovative solutions designed to improve outcomes, efficiency and productivity in electrophysiology labs worldwide.

Source: St. Jude Medical, Inc.