Mapping the Heart to Tailor Treatment
Our EnSite Precision mapping system is designed to provide doctors more information for treating abnormal heart rhythms.
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Healthy Heart | Feb. 10, 2017

With its rainbow colors, the image has an unexpected beauty. But its real appeal lies in the information it provides to doctors treating cardiac arrhythmias (abnormal heart rhythms). That’s because this image, which comes from Abbott's newly launched EnSite Precision cardiac mapping system, is just part of a much more detailed display showing the electrical activity in a patient’s heart.

Highly detailed three-dimensional model

The highly detailed, three-dimensional models and maps that the EnSite Precision system provides help doctors more effectively diagnose — and treat — irregular heart rhythms.

Since its approval by the United States Food and Drug Administration in December, the EnSite Precision system – which came to Abbott through our recent acquisition of St. Jude Medical — has already been used in 12 U.S. states. The technology also has been used to help more than 15,000 patients in 29 countries outside the U.S.

So Why Is Having a Detailed Map So Important?

To understand that, you need to know about the heart’s "electrical system." It's complicated, but the short version is this: Your heartbeat is governed by a series of electrical impulses that start — if everything's functioning properly — in a group of cells at the top of your heart. Each impulse travels through the upper chambers of your heart (the right and left atria), pumping blood into the lower chambers, called ventricles. At this point, the electrical impulse moves into a group of cells between the upper and lower chambers where it is slowed down, giving the ventricles time to fill up with blood. The impulse then moves to the ventricles, causing them to contract and pump blood to the lungs and the rest of your body. Once the ventricles relax, the process starts over again.

However, if you have atrial fibrillation (AF) – and, according to the U.S. Centers for Disease Control and Prevention, as many as 6.1 million people in the United States alone could have the condition — these electrical impulses can become disorganized. The muscle cells in your atria twitch in an uncoordinated way, and your heart doesn’t pump efficiently. This can lead to blood pooling in the atria and subsequently to the formation of blood clots. If one of these clots traveled to the brain, it could cause a stroke.

Many people with AF are treated with medication that reduces symptoms but doesn't actually address the underlying problem. But some people with AF undergo a catheter-based procedure known as ablation. In an ablation procedure, doctors try to destroy the abnormal tissue that's disrupting the normal flow of electrical signals.

Before the invention of mapping technology like Abbott's, if a patient had multiple arrhythmias it was very time consuming to figure out the source of the problem. In addition, the tools were not always precise enough to fully understand the patient’s underlying and specific physiology. As a result of this, cardiac ablation procedures using older technology could be frustrating and provide sub-optimal results.

Our Technology is Designed to Change That.

In addition to providing detailed maps, EnSite Precision allows catheter navigation during procedures to treat irregular heart rhythms to occur with minimal medical x-ray imaging. That means there’s less potential for health risks that are linked to excessive radiation exposure.

It also introduces new solutions, such as the EnSite AutoMap Module, which helps doctors more quickly identify the source of an irregular heartbeat and enables physicians to build a map of the heart 10 times faster than current systems.

"We expect the EnSite Precision cardiac mapping system to become the new standard for identifying abnormal heart rhythms when tailoring treatment for patients suffering from arrhythmias," said Srijoy Mahapatra, M.D., Medical Director of Abbott's electrophysiology business.

With innovation like this, Abbott is better able than ever to help people get healthy, and get back to living their fullest possible lives.

INDICATIONS, SAFETY & WARNINGS

CAUTION:

This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR, when used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Warnings: Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

PRECAUTIONS:

Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision Field Frame cable. If placed this close—particularly if the cables are parallel to each other—the tool cable may become subject to electromagnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.