US FDA approves Abbott's advanced mapping catheter

Arrhythmias are abnormal heart rhythms caused by improperly conducted electrical signals in the heart. In the US, 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.

The new Advisor HD Grid catheter is designed to capture information such as the direction and speed of cardiac signals -- often missed with traditional mapping catheters. Advisor HD Grid offers physicians a unique grid configuration that captures this critical information and enables the creation of high-density maps of cardiac tissue to support optimal treatment for patients. With the Advisor HD Grid mapping catheter, 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 visualisearrhythmias in much greater detail, and we are confident that patient outcomes will improve as a result."

As an added benefit for physicians, the Advisor HD Grid mapping catheter was designed with Sensor EnabledTM technology, which can help optimise the accuracy of the cardiac image and provide physicians additional flexibility when pairing the catheter with the EnSite Precision cardiac mapping system.

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

The Advisor HD Grid Mapping Catheter, Sensor Enabled received CE Mark approval in December 2017 and further expanded Abbott's comprehensive portfolio of mapping and treatment catheters. Combined, the portfolio has helped improve how physicians approach the treatment of complex arrhythmias and atrial fibrillation and introduced a new level of innovation into the electrophysiology market. The Advisor HD Grid mapping catheter has been used in 20 countries since its European launch and the company expects commercial use to begin across the US in the coming months.

Us fda approves, abbott's advanced mapping catheter