On 2 November 2020, Abbott announced that it has received CE Mark and approval in Australia for its new EnSite X EP System and is launching the system throughout Europe and Australia. The EnSite X System is the only system that offers the option to navigate the cardiac anatomy two different ways on one platform. Abbott sought physician feedback to develop the EnSite X System to meet current needs and address emerging opportunities during cardiac ablation procedures. The new cardiac mapping platform builds upon its electrophysiology portfolio and is designed to improve how physicians deliver ablation therapy to treat abnormal heart rhythms.
Cardiac mapping systems allow electrophysiologists to create a heart map, helping them get a clear picture of the electrical signals that control cardiac rhythms. Once a map is created, physicians can identify electrical disruptions—or areas of the heart causing heart rhythm problems and ablation therapy to treat the issue. Cardiac ablation is a minimally invasive procedure that can treat abnormally fast heartbeats by creating lesions (ablations) in small heart tissue areas that a physician has identified as causing the arrhythmia.
According to Abbott, the EnSite X System has advanced imaging capabilities that allow for creating a three-dimensional (3D) model of the patient’s cardiac anatomy in real-time, allowing physicians to see areas of the heart need ablation treatment. Physicians can choose traditional impedance monitoring (using the heart’s mechanical activity) or electromagnetic technology, which allows precise location of Abbott’s sensor-enabled catheters during treatment.
“The new EnSite X System will fundamentally change how physicians approach longer, more complex ablation procedures as a result of its improved stability, faster mapping and better model visualization,” said Paolo Della Bella, head of the Department of Cardiac Electrophysiology and Arrhythmology at IRCCS San Raffaele Hospital, Milan, Italy. “In my first cases with the system it’s been apparent that the system is an important step forward in terms of technological capabilities and also truly helps improve my clinical analysis by protecting for patient movements.”
The various aspects of the EnSite X System are designed to work in harmony and allow ongoing updates as technology advances. The new mapping system is among a series of product-focused activities from Abbott designed to improve patient care and meet the needs of electrophysiologists around the world.
The company also recently secured the US Food and Drug Administration (FDA) and CE Mark approval for the EnSite LiveView Dynamic Display, which allows data from the Advisor HD Grid mapping catheter, Sensor Enabled be visualized in real-time during cardiac ablation procedures. The Advisor HD Grid catheter, SE, is designed to capture information often missed with traditional mapping catheters. Additionally, physicians use magnetically sensor-enabled technology, such as the TactiCath Contact Force Ablation Catheter, Sensor Enabled, for precise location and navigation within the heart.
“The high-density cardiac mapping capability this new system offers helps me to more quickly and accurately collect data and diagnose arrhythmias,” said Isabel Deisenhofer, head of Electrophysiology at the German Heart Center, Munich Germany. “The combination of the EnSite X System with the Advisor HD Grid mapping catheter, SE allows me to most effectively treat each patient’s unique needs without having to compromise our workflow in the EP lab.”
The EnSite X EP System is currently pending 510(k) clearance from the US Food and Drug Administration.
When physicians use catheter ablation to treat cardiac arrhythmias, long flexible tubes — called catheters — are inserted into the heart to study the arrhythmia and deliver radiofrequency energy. The heat generated from the radiofrequency energy creates a scar on the tissue where the abnormal heartbeats originate. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia.
The Abbott electrophysiology (EP) business is one of the fastest-growing segments within the company’s broader device portfolio. The Abbott EP product portfolio gives physicians the diagnostic, access, mapping, and therapy solutions they need with designed integration for enhanced diagnosis and treatment of heart arrhythmias. A leader in collaborating with world-renowned electrophysiologists, clinicians, and hospital administrators, Abbott develops safe and cost-effective treatment solutions for patients in need of advanced ablation therapies.