Healthcare Industry News: U.S. Food and Drug Administration
News Release - May 3, 2018
Abbott Expands Cardiac Arrhythmias Portfolio with FDA Clearance of Advanced Mapping CatheterADVISOR™ HD GRID MAPPING CATHETER, SENSOR ENABLED™ FACILITATES IMPROVED DATA COLLECTION, SUPPORTING OPTIMAL TREATMENT FOR PATIENTS WITH COMPLEX CARDIAC ARRHYTHMIAS
FIRST-OF-ITS-KIND GRID CONFIGURATION IS DESIGNED TO CAPTURE DATA IN MULTIPLE DIRECTIONS TO CREATE HIGH-DENSITY MAPS OF THE HEART
NOVEL MAPPING CATHETER COMPLEMENTS THE ENSITE PRECISION™ CARDIAC MAPPING SYSTEM AND EXPANDS ABBOTT'S ADVANCED CARDIAC MAPPING PORTFOLIO
ABBOTT PARK, Ill., May 3, 2018 -- (Healthcare Sales & Marketing Network) -- Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. Advisor HD Grid employs a new design that allows physicians to see things differently, 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 mapping catheter builds upon Abbott's innovative products designed to improve how physicians perform cardiac ablation procedures, including the EnSite Precision Cardiac Mapping System and a broad range of mapping and treatment catheters.
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.1 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 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 Advisor HD Grid mapping catheter was designed with 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 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, 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 U.S. in the coming months.
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
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1 cdc.gov. (2017). Atrial Fibrillation Fact Sheet|Data & Statistics|DHDSP|CDC. [online] Available at: https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm [Accessed 10 Nov. 2017].
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