Technology | EP Mapping and Imaging Systems | January 03, 2017

St. Jude Medical Announces FDA Clearance of EnSite Precision Cardiac Mapping System

System enables faster, more accurate heart mapping during catheter ablation to optimize treatment for patients with cardiac arrhythmias

St. Jude Medical, EnSite Precision cardiac mapping system, FDA clearance, catheter ablation

January 3, 2017 — St. Jude Medical Inc. announced U.S. Food and Drug Administration (FDA) clearance of its EnSite Precision cardiac mapping system and Advisor FL Circular Mapping Catheter, Sensor Enabled in December.

The new EnSite Precision cardiac mapping system is the latest addition to the company’s electrophysiology portfolio, and is designed to provide automation, flexibility and precision in cardiac mapping during the treatment of patients with abnormal heart rhythms (cardiac arrhythmias). This next-generation platform has been used in thousands of cases in electrophysiology labs and hospitals across Europe since receiving CE Mark in January 2016.

When physicians use catheter ablation to treat abnormal heart rhythm, a small area of heart tissue under the tip of the ablation catheter is heated by high-frequency energy, creating a lesion or tiny scar. As a result, this tissue is no longer capable of conducting or sustaining the arrhythmia. Cardiac mapping provides a live view of the heart so physicians can visualize and navigate cardiac anatomy to deliver more precise ablation therapy. The new EnSite Precision cardiac mapping system offers a new dual-technology platform that provides highly detailed anatomical models and maps to enable more efficient treatment of a wide range of arrhythmias — including complex arrhythmias, such as atrial fibrillation or ventricular tachycardia.

“The new EnSite Precision cardiac mapping system allows more mapping data to be collected in a shorter amount of time compared to today’s technologies,” said John Day, M.D., medical director of the Intermountain Heart Rhythm Specialists at the Intermountain Medical Center Heart Institute in Salt Lake City, who is set to perform the first case in the United States. “We look forward to implementing the EnSite Precision cardiac mapping system and the new St. Jude Medical Sensor Enabled tools to help guide therapy and provide expanded procedural options to tailor care for patients in simple to complex ablation scenarios, as well as deliver a new level of accuracy and speed in our procedures.”

The EnSite Precision system introduces new solutions, including the EnSite AutoMap Module, which will enable the electrophysiologist to more quickly perform morphology matching that identifies the source of the irregular heartbeat using automated cardiac rhythm mapping tools to facilitate treatment. The AutoMap Module includes the new TurboMap feature, which will allow the physician to build a map of the heart 10 times faster than current systems using recorded data.

For more information: www.sjm.com

Related Content

Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems | December 08, 2017
December 7, 2017 — Stereotaxis Inc.
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems | October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems | October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems | August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems | July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems | May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems | May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems | February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems | January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems | November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Overlay Init