The Marlborough, Mass.-based medical device giant said the 100-patient AF-ficient I study of intermittent AF proceeded in two stages. Phase one, testing the original Luminize design, showed a pulmonary vein isolation rate of 88.9%; phase two, testing enhanced steering and electrodes, showed a PV isolation rate of 99.4%. The median balloon dwell time dropped from 92 minutes in the first phase to 29 minutes in the second, bringing total procedure time down to a median 71 minutes. There were no device-related serious adverse events in either phase at 30 days, Boston Scientific said.
The results were presented March 17 at the annual meeting of the European Heart Rhythm Assn. in Lisbon.
“The study assessed the safety and effectiveness of isolating PVs through the combined benefits of RF and balloon-based ablation, both of which are found in the Luminize RF balloon catheter,” principal investigator Dr. Amin Al-Ahmad, of Austin’s Texas Cardiac Arrhythmia center, said in prepared remarks. “The data underscore the potential for this catheter to improve procedural efficacy and patient outcomes.”
“We are pleased with the data presented today as it highlights the potential benefits of the LUMINIZE RF Balloon Catheter,” added rhythm management and global health policy CMO Dr. Kenneth Stein. “By providing real-time visualization both before and during ablation and individualized control of electrode energy levels, this technology may allow physicians to swiftly and accurately isolate veins and decrease procedure times.”
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