May 3, 2018 — The U.S. Food and Drug Administration (FDA) has granted market clearance for the Abbott Advisor HD Grid Mapping Catheter, Sensor Enabled. The new electrophysiology (EP) mapping catheter design allows physicians to see things differently during transcatheter EP cardiac ablation procedures. This includes capturing and analyzing data in a novel manner to create highly detailed maps of the heart that better differentiate healthy from unhealthy tissue.
The new catheter is designed to capture information, such as the direction and speed of cardiac signals, which is often missed with traditional mapping catheters. The Advisor HD Grid offers a unique grid configuration that captures this information and enables the creation of high-density electro maps of cardiac tissue to support optimal treatment. The vendor said for the first time, physicians can see electrical signals that they may have missed using standard mapping catheters.
"At the University of Chicago Medicine, we are passionate about understanding and redefining arrhythmia mechanisms with higher resolution cardiac mapping. 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, M.D., associate professor of medicine and director of cardiac electrophysiology at the University of Chicago Hospitals. "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."
As an added benefit for physicians, the new mapping catheter was designed with Abbott's Sensor Enabled technology, which can help optimize the accuracy of the cardiac image and provide physicians additional flexibility when pairing the catheter with the EnSite Precision cardiac mapping system.
The Advisor HD Grid Mapping Catheter, Sensor Enabled received European CE mark approval in December 2017. The catheter has been used in 20 countries since its European launch and the company expects commercial use to begin across the U.S. in the coming months.
Arrhythmias are abnormal heart rhythms caused by improperly conducted electrical signals in the heart. In the U.S., more than 7 million people have an irregular heartbeat. Abnormal heart rhythms, which include conditions such as atrial fibrillation, make the heart beat too fast, too slow or out of sync. In each case, the heart may pump blood less effectively which can cause a range of symptoms that disrupt a patient's quality of life. In some cases, cardiac arrhythmias can damage the heart or cause blood clots, strokes or cardiac arrest.
For people battling complex arrhythmias, physicians may use cardiac ablation therapy to create lesions on the heart to disrupt the electrical pathways causing the erratic heart beats. To ensure the best outcomes for their patients, physicians first need to identify which areas of the heart contain those pathways. Mapping catheters are critical to providing this insight — delivering an inside view of the heart so physicians can navigate cardiac anatomy to deliver more precise ablation therapy.
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1. Atrial Fibrillation Fact Sheet|Data & Statistics|DHDSP|CDC. cdc.gov. (2017) [online] Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm [Accessed 10 Nov. 2017].