HD Grid Mapping Catheter for Cardiac Ablation Receives FDA Clearance

The US Food and Drug Administration (FDA) has cleared Abbott’s Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (Advisor HD Grid), a newly-designed tool that allows doctors to visualize and map healthy and unhealthy heart tissue.

The Advisor HD Grid builds upon previous Abbott products, including the EnSite Precision Cardiac Mapping System and a broad range of mapping and treatment catheters, that allow physicians to better perform cardiac ablation procedures.

The new catheter’s novel grid configuration was designed to collect data in multiple directions, resulting in a high-density map of the patient’s heart. The Advisor HD Grid captures information including the direction and speed of cardiac signals that traditional mapping catheters often miss.

"Abbott's Advisor HD Grid represents an important step in the development of next generation mapping catheters. With a flexible and soft design using magnetic sensor technology, the catheter helps capture signals previous catheters may have missed to support the creation of highly detailed 3D maps of the heart," said Roderick Tung, MD, associate professor of medicine and director of cardiac electrophysiology at the University of Chicago Hospitals. “At the University of Chicago Medicine, we are passionate about understanding and redefining arrhythmia mechanisms with higher resolution cardiac mapping.”

Catheter ablation has been shown to significantly improve outcomes for patients with atrial fibrillation with ventricular dysfunction when compared to conventional drug treatment. The Advisor HD Grid will allow physicians to create detailed maps of a patient’s heart before performing the procedure, thereby improving accuracy and patient outcomes.

"Innovation within the field of electrophysiology continues to evolve toward improving our ability to visualize arrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result," said Tung.

Cardiac arrhythmias affect many Americans, including an estimated 2.7—6.1 million with atrial fibrillation. These conditions are characterized by heartbeats that are out of sync, too slow, or too fast. Abnormal heart rhythms cause a range of symptoms and can lead to heart damage, blood clots, strokes, or cardiac arrest.

"The goal in developing the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ was to provide physicians with an innovative solution to quickly and accurately map complex arrhythmias in patients," said Srijoy Mahapatra, MD, FHRS, medical director of Abbott's electrophysiology business.

The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ has been used in 20 countries since it received CE Mark approval for use in much of Europe in December 2017. With FDA clearance, Abbott expects to have the Advisor HD Grid available for commercial use in the coming months.