Boston Scientific (NYSE:BSX) today released data from the True-HD study of its Rhythmia mapping system and Intellamap Orion mapping catheter, touting it as safe and effective to support treatments of arrhythmias.
Results from the trial were presented at a late-breaking clinical trial session at the European Heart Rhythm Association’s annual congress in Barcelona, Spain.
The 572-patient True-HD study aimed to explore procedural process, acute success and safety for mapping and ablation of clinical arrhythmias using the Rhythmia and Intellamap Orion devices, the Marlborough, Mass.-based company said.
“This study was the first to perform systematic data collection on a range of arrhythmia types using the Rhythmia mapping system. 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,” principal investigator Dr. Gerhard Hindricks of Germany’s Leipzig University Heart Center said in a prepared statement.
Results from the trial indicated an acute success rate of 95.7%, Boston Scientific said, with the Rhythmia mapping system allowing physicians to assess therapy efficacy and determine if other arrhythmias were present. Mapping validation in the trial identified the need for additional ablations in 73% of patients, the company said.
Ablation-related complications in the trial were low and similar to those submitted in other recent studies, with only 0.6% potentially related to the mapping, the company said.
“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. 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,” Boston Scientific rhythm management and global health policy chief medical officer Dr. Kenneth Stein said in a prepared release.
Boston Scientific launched a next-gen Rhythmia HDx mapping system last year which featured updated design for future cardiac mapping innovations and improved workflow efficiency.
Boston Scientific won FDA pre-market approval for the Rhythmia system in May 2016, after having acquired the technology when it bought Rhythmia Medical in 2012.
