FDA approves ablation catheter for patients with atrial flutter
The FDA approved the FlexAbility Ablation Catheter, Sensor Enabled for patients with atrial flutter.
Abbott announced the approval in a news release on March 1.
The company said the FlexAbility is the second sensor-enabled tool approved for use with its EnSite Precision cardiac mapping system. The sensor-enabled feature allows physicians to collect magnetic data. The other sensor enabled tool is the Advisor FL Circular Mapping Catheter.
In January, Abbott completed its acquisition of St. Jude Medical, which developed the FlexAbility ablation catheter. The St. Jude Medical deal helps Abbott gain a stronger foothold in the atrial fibrillation market.
With the EnSite Precision system and the FlexAbility ablation catheter, physicians can create 3D cardiac models with the heart’s electrical activity overload on it, which Abbott said enables physicians to identify the type of arrhythmia and the areas they should treat. The company added that the catheter is compatible with its MediGuide technology, as well.
“I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients,” Jeffrey Winterfield, MD, director oVentricular Arrhythmia Service and associate professor of cardiac electrophysiology at the Medical University of South Carolina. "Sensor Enabled catheters, along with EnSite Precision cardiac mapping system, allow me to quickly identify and treat the arrhythmia, giving me the flexibility and accuracy I need to reach the most challenging locations in the heart to support effective outcomes and improve the lives of my patients.”