St. Jude Medical (STJ) Unleashes EnSite Precision Cardiac Mapping System in Europe

October 5, 2016 8:33 AM EDT

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St. Jude Medical, Inc. (NYSE: STJ) announced a full market release of its EnSite Precision™ cardiac mapping system and new Sensor Enabled™ tools in Europe. The new platform is now installed and active in more than 100 sites across Europe and has been used to support more than 5,000 ablation cases since the system’s CE Mark approval in January 2016.

Used in ablation procedures to visualize and navigate catheters in the heart, the EnSite Precision cardiac mapping system provides highly detailed anatomical models and maps to effectively enable diagnosis of a wide range of arrhythmias (abnormal heart rhythms) — including complex cases of atrial fibrillation and ventricular tachycardia — and guide therapy. The system combines magnetic and impedance technologies to transform procedures with intuitive automation, expanded procedural options and tailored care using superior flexibility and it allows effective management of patients through greater accuracy.

“I see the most significant impact of this technological platform in supporting ablation cases in patients with complex and advanced cardiac arrhythmias,” said Prof. Gerhard Hindricks, director of the Department of Electrophysiology at University of Leipzig Heart Center in Germany. “Today, we are seeing more and more patients with complex and demanding cardiac arrhythmias, which require a very, very precise and fast analysis and ablation strategy. The EnSite Precision platform supports it all, from fast access to target sites, fast and precise mapping data generation to automatic data analysis.”

The EnSite Precision cardiac mapping system is flexible and enhances workflow efficiency by allowing physicians to optimize mapping of the heart chambers using the new St. Jude Medical™ Sensor Enabled toolset and customize procedures to address the circumstances of each case. The FlexAbility™ Ablation Catheter, Sensor Enabled™ can enhance procedural versatility and precision; it combines an advanced handle with a bendable irrigated catheter tip to conform to the cardiac anatomy allowing for effective lesion formation. Designed for advanced handling and maneuverability, the Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ allows for precise navigation and model creation with impedance-field flexibility and magnetic-field stability.

The EnSite Precision cardiac mapping system also allows real-time catheter navigation to occur using minimal fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure for patients and clinicians.

“We collaborated with leading electrophysiologists to develop a cardiac mapping system that provides the automation, flexibility and precision needed during today’s ablation procedures,” said Dr. Mark Carlson, chief medical officer and vice president of medical affairs at St. Jude Medical. “We are extremely pleased with how the physicians from these European sites have embraced the system and are excited to expand its availability as we seek more approvals.”

In addition to Europe, the EnSite Precision cardiac mapping system is available in other markets, including Hong Kong and Singapore. St. Jude Medical is pursuing Food and Drug Administration clearance to make the system available in the United States.

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