FDA greenlights Abbott’s sensor-enabled flexible ablation catheter

Physicians can use the sensor-enabled FlexAbility catheter with Abbott's EnSite Precision cardiac mapping system.

Abbott scored FDA approval for its sensor-enabled catheter for the treatment of atrial flutter, a type of cardiac arrhythmia. It is the company’s first ablation catheter that collects data to facilitate mapping in addition to treating the arrhythmia.

Picked up in Abbott’s acquisition of St. Jude Medical, the FlexAbility Ablation Catheter, Sensor-Enabled is based on the latter’s FlexAbility platform, the first irrigated ablation catheter with a flexible tip to hit the U.S. market.

The sensor-enabled version collects electrical current resistance and magnetic data to enable detailed and accurate mapping, the company said in a statement. It may be used with the EnSite Precision cardiac mapping system and the company’s MediGuide Technology. Both systems were also acquired in the St. Jude deal.

"We are continuing to innovate around the EnSite Precision cardiac mapping system to create an ablation portfolio that best supports physicians looking to tackle even the toughest cases," Srijoy Mahapatra, M.D., medical director of Abbott's electrophysiology business, said in the statement. " ... [the sensor-enabled catheter] offers the ability to engage the magnetic platform for enhanced precision, especially when physicians encounter a complex case."

When the catheter is paired with the EnSite system, the physician may create 3D cardiac models with an overlay showing the heart’s electrical activity, the company said. This help the physician determine the type of arrhythmia and identify areas that he or she should ablate.

"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" said Jeffrey Winterfield, M.D., director of ventricular arrhythmia service and associate professor of cardiac electrophysiology at the Medical University of South Carolina, in the statement. "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."