Late-breaking Clinical Trial Data Further Demonstrate Safety and Effectiveness of the RHYTHMIAtm Mapping System

BARCELONA, Spain and MARLBOROUGH, Mass., March 20, 2018 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced real-world data from the TRUE-HD study during a late-breaking clinical trial session today at the annual congress of the European Heart Rhythm Association (EHRA) in Barcelona, Spain. The data demonstrated the RHYTHMIAtm Mapping System, when paired with the INTELLAMAP ORIONtm Mapping Catheter, continues to be safe and effective for mapping and to support treatment of a wide variety of arrhythmias, including a cohort of patients who had unsuccessful ablation of atrial fibrillation using other techniques.  

The global TRUE-HD study examined procedural process, acute success and safety for the mapping and ablation of various clinical arrhythmias. Depending on the arrhythmia type, study data showed an acute success rate of up to 95.7%. In 222 patients, procedure process included the creation of validation maps to confirm the termination of an arrhythmia. Utilization of the RHYTHMIA Mapping System vMaptm feature allowed physicians to rapidly assess therapy efficacy and determine if other arrhythmias were present. When completed, validation mapping identified the need for additional ablations in 73.0% of patients.

"This study was the first to perform systematic data collection on a range of arrhythmia types using the RHYTHMIA Mapping System," said Gerhard Hindricks, M.D., principal investigator and head of the electrophysiology department at Leipzig University Heart Center in Germany. "Importantly, validation mapping allowed for precise views of therapy success and the identification of new areas in the heart requiring additional ablations that would have otherwise gone untreated."

The observational, prospective, non-randomized study enrolled 572 patients eligible for cardiac mapping and ablation to treat an arrhythmia, with the exception of those diagnosed with de novo atrial fibrillation. The ablation-related complications were low and similar to those reported in recent literature¹, with only 0.57% potentially related to the mapping catheter.

"The data presented today underscore the value that the RHYTHMIA Mapping System and INTELLAMAP ORION Mapping Catheter bring to physicians as they diagnose and treat a broad array of arrhythmias," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. "We look forward to the continued expansion of our electrophysiology portfolio and future innovations that ensure physicians are equipped with tools that provide the highest quality care for their patients."

Last year the company launched the next generation RHYTHMIA HDxtm Mapping System featuring an updated design to support future cardiac mapping innovations and improve workflow efficiency.

For more information on the RHYTHMIA HDx Mapping System and the INTELLAMAP ORION Mapping Catheter, visit www.bostonscientific.com/rhythmia.

About Boston Scientific 
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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¹ Haegeli LM, Catheter ablation of atrial fibrillation: an update. Eur Heart J., 2014(36): p. 2454-9.

SOURCE Boston Scientific Corporation