Boston Scientific touts safety, effectiveness in Rhythmia mapping study

May 16, 2018 By Fink Densford Leave a Comment

Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company.

Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure.

Findings from the study were presented at the EHRA 2018 meeting, according to Healio.

The primary endpoint of the trial was acute procedural success as defined by assessing the ability to map an arrhythmia or its substrate, completion of ablation applications and arrhythmia termination where applicable, with validation through appropriate techniques, according to the report.

Investigators reported that 83.3% of patients treated had successful procedures confirmed by arrhythmia-specific validation techniques. They also reported 96% success rate in treating cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias, Healio reported.

Median time or map acquisition during procedures was 29 minutes and 41 seconds, with 73% of patients who had maps collected requiring additional ablation after validation mapping, according to the report.

A total of 61 adverse events in 49 patients were document, with 4% being ablation-related complications and 0.6% related to the mapping catheter, Healio reports.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy. Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the True-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available,” Dr. Gerhard Hindricks of Germany’s Leipzig University Heart Center said, according to the report.

Yesterday, Boston Scientific released data from the Ranger SFA trial that showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty.

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