St. Jude Medical (NYSE:STJ) said today it won Japanese MHLW approval for its EnSite Precision cardiac mapping system and its TactiCath irrigated ablation catheter.
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.
The St. Paul, Minn.-based company’s TactiCath quartz irrigated ablation catheter is designed for ablation procedures to treat atrial fibrillation. St. Jude touted the device as being designed to allow for “more control” of force during ablation procedures to create “more effective lesions.”
“Our new EnSite Precision cardiac mapping system was designed to give the physician a means to precisely navigate within the heart, provide higher density diagnostic data to better inform their diagnosis and allow them to use the tools that make sense for each individual patient and situation. The system’s intelligent automation tools enable faster, more accurate high-density maps with greater consistency across cases, which are important factors in addressing the needs of today’s EP labs,” clinical, medical & scientific affairs veep Dr. Srijoy Mahapatra said in a prepared statement.
“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 a prepared release.
“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.
Last month, St. Jude said it fully launched its EnSite Precision cardiac mapping system and associated tools in Europe, expanding from an earlier limited release.
The 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.
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.