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Abbott Expands Cardiac Arrhythmias Portfolio With FDA Clearance of Advanced Mapping Catheter

First-of-its-kind grid configuration is designed to capture data in multiple directions to create high-density maps of the heart.

Abbott 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.

The Conversation

NEW COVERAGE DECISION EXTENDS ABBOTT'S INNOVATIVE PAIN THERAPY OPTION TO 22 MILLION AMERICANS LIVING WITH CHRONIC PAIN

Abbott is the only company in the world with FDA and CE Mark approval to offer dorsal root ganglion (DRG) neurostimulation therapy to treat complex nerve pain conditions.

Originally Published by Abbott.

Abbott announced a new national coverage determination for the company's dorsal root ganglion (DRG) neurostimulation pain therapy through Aetna®, a leading health benefits company in the United States. With this coverage decision, Aetna will provide more than 22 million medical plan members with access to Abbott's DRG therapy for people with chronic pain.

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Abbott: Expediting Blood Testing With i-Stat

The portable, handheld i-STAT Alinity delivers quick blood test results anywhere you are.

Originally Published by Abbott.

Every day, countless blood samples are tested all around the world for one purpose: to help diagnose and treat medical conditions. From the couple eagerly awaiting the results of a pregnancy blood test to a worried cancer patient hoping for more answers, diagnostic blood tests give vital insight into what's happening underneath the skin.

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Abbott: Freestyle Libre 14 Day, Now FDA Approved

Abbott's flash glucose monitor now FDA-approved for two weeks of use in U.S. between sensor changes.

Originally Published by Abbott.

The U.S. Food and Drug Administration has approved FreeStyle Libre 14 day— Abbott's revolutionary continuous glucose monitoring system. In the U.S., you can wear the sensor up to 14 days with high accuracy.

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​Abbott Announces Freedom 2 Save Program For Employees To Address Student Debt

Two-thirds of millennials aren't saving for retirement; benefit means student debt won't prevent retirement savings.

Originally Published by Abbott.

Historic levels of student debt have forced many people to choose between saving for their futures and paying off school loans. Abbott announced a groundbreaking program that addresses the student debt crisis and changes that math.

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Abbott: Connected Devices Turn Data Into Better Health

Abbott's Robert Ford Joins a Panel Discussing the Potential for Connected Medical Devices to Improve Patient Care and Drive Better Outcomes.

Originally Published by Abbott.

Today's medical devices are creating terabytes of information that gives patients, doctors and health providers real-time insight into someone's vital statistics, heart health and even bloodwork.

But can all this new information really make someone healthier?

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Abbott Introduces the Afinion™ 2 Analyzer Rapid Test System for Diabetes Management

State-of-the-art multi-assay test system helps people with diabetes get the HbA1c results they need within three minutes — allowing more time for consultation and care during a single healthcare visit.

Originally Published by Abbott.

Abbott announced the launch of its Afinion™ 2 analyzer in the U.S., the newest generation of the Afinion test system. The Afinion 2 builds on Abbott's heritage in diabetes care by empowering patients with information about their health that they can discuss with their providers during a single visit.

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Abbott's Xience Sierra Heart Stent Receives National Reimbursement in Japan to Treat People with Coronary Artery Disease

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan.

Originally Published by Abbott.

Abbott announced that Japan's Ministry of Health Labour and Welfare (MHLW) granted national reimbursement for XIENCE Sierra™, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent. XIENCE Sierra improves upon previous versions of XIENCE with an enhanced stent design, a new delivery system, and unique sizes to help doctors treat challenging cases.

XIENCE Sierra was designed to help doctors more easily treat people with difficult-to-treat blockages that involve multiple or totally blocked arteries or complications such as diabetes. Complex cases are increasingly prevalent as people with coronary artery disease are living longer.

"Extensive clinical data and 10 years of real-world experience with the XIENCE family of stents provide doctors with confidence that they are treating their patients with one of the safest stents available," said Chuck Brynelsen, senior vice president of Abbott's vascular business. "National reimbursement of XIENCE Sierra will provide people in Japan with greater access to this life-changing technology that can help them live their best lives."

Coronary artery disease is the most common form of heart disease, which is the second leading cause of death in Japan. National reimbursement in Japan will enable doctors to treat more patients with XIENCE Sierra through the country's health insurance plans. XIENCE Sierra was approved in Japan on April 4, 2018, received CE Mark in Europe late last year, and is under review with the U.S. Food and Drug Administration.

XIENCE has been studied in over 100 clinical trials and in 10 years of global real-world experience. Its safety profile is unprecedented with consistent low rates of stent thrombosis, even in complex cases. More than eight million people worldwide have received a XIENCE stent since its initial regulatory approval.