The St. Paul, Minn.-based company touted more than 100 installations of the device across Europe so far, supporting more than 5,000 ablation procedures after a targeted release it expanded in April.
“We collaborated with leading electrophysiologists to develop a cardiac mapping system that provides the automation, flexibility and precision needed during today’s ablation procedures. 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,” chief medical officer Dr. Mark Carlson said in a press release.
The Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps, St. Jude said. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options.
“I see the most significant impact of this technological platform in supporting ablation cases in patients with complex and advanced cardiac arrhythmias. 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,” Gerhard Hindricks of Germany’s University of Leipzig Heart Center said in prepared remarks.
The company won CE Mark approval for the device in January, and is currently pursuing FDA clearance to release the system in the U.S.